Reports for Product Code HIB
Description of Event or Problem: Disposable speculum inserted by md, opened when correctly positioned. Upon completion of exam, md unable to unlock speculum for removal. speculum removed in the open position causing some discomfort to patient. no patient injury.
Additional Manufacturer Narrative: According to the customer, on (b)(6) 2024 during a vaginal exam the speculum broke inside the patient when it was "inserted and opened". The customer reported after the speculum broke the provider removed the broken piece with "an instrument". The customer reported the patient is doing "fine" and the procedure...show all
Description of Event or Problem: According to the customer, on (b)(6) 2024 during a vaginal exam the speculum broke inside the patient when it was "inserted and opened".
Description of Event or Problem: The package label for trinity sterile's disposable vaginal speculum large (item no. 22202) and, presumably, other sizes, gives the impression that the product is sterile when it is not. The word sterile appears in very large letters at the top of the package label (as part of the brand name...show all
Description of Event or Problem: Lights on our large lighted speculums are not bright enough to use.
Description of Event or Problem: It was reported that during an annual gyn exam and pap, with use of a kleenspec (size small), the ¿lower bill of speculum broke, split lengthwise¿ during use. The customer states a ¿small amount of vaginal bleeding¿ occurred, however there was no allegation of medical intervention or delay from the...show all
Additional Manufacturer Narrative: During follow up with the customer, it was noted, ¿the nurse who was using the specula was able to remove it and use another specula of the same size without incident.¿ the patient is a 59-year-old female weighing 230 pounds. As a precaution, all materials from this lot were taken...show all
Description of Event or Problem: While doctor was performing a vaginal exam, the plastic speculum broke causing vaginal lacerations.
Description of Event or Problem: Per emailed medwatch received by product surveillance from customer service : "provider was utilizing the anoscope for assessment. Upon removal of the stylet it was noted that the cap on the end was not attached. The cap had remained in the speculum that was still in the patient. When the...show all
Additional Manufacturer Narrative: Investigation. No sample returned. Analysis and findings: distribution history. The complaint product was purchased from carclo technical plastics. Manufacturing record review: manufacturing record review not applicable to this product. Incoming inspection review: incoming inspection record review not applicable to this product. Service history record: service history not applicable for this...show all
Additional Manufacturer Narrative: Coopersurgical, inc. Is currently investigating the reported condition.
Description of Event or Problem: Per emailed medwatch received by product surveillance from customer service : "provider was utilizing the anoscope for assessment. Upon removal of the stylet it was noted that the cap on the end was not attached. The cap had remained in the speculum that was still in the patient. When the...show all
Description of Event or Problem: Provider was utilizing the anoscope for assessment. Upon removal of the stylet, it was noted that the cap on the end was not attached. The cap had remained in the speculum that was still in the patient. When the speculum was removed, the cap was removed with it. No harm...show all
Additional Manufacturer Narrative: Hillrom is reporting this event in an abundance of caution. The disposable vaginal speculum is used to dilate the vagina and expose the interior of the vagina and exterior of the cervix during pelvic examinations and other gynecological procedures. The vaginal speculum can be used with or without the illuminator....show all
Description of Event or Problem: The customer reported while performing a pap test on a patient, vaginal speculum disposable premium 590 series large broke off inside of our patients vaginal cavity. The customer additionally clarified that during the exam, the bill of the spec broke off in the patient. The patient did not sustain any...show all
Description of Event or Problem: Customer stated - lot # 21a1102z for item # c020110-1 was reported by the emergency department that on three occasions the item broke in half when in use and in one case the product broke in the patient. Broken piece on speculum retrieved without injury to patient. (b)(6) 2021- follow-up...show all
Additional Manufacturer Narrative: Investigation no sample returned review dhr inspect stock product *analysis and findings distribution history the complaint product was purchased from coopersurgical sister company (obp) and sold to the customer under lot number 21a1102z. Manufacturing record review dhr for lot number 21a1102z was reviewed and no non-conformities, related to the complaint...show all
Additional Manufacturer Narrative: Coopersurgical, inc. Is currently investigating the reported condition.
Description of Event or Problem: Customer stated : lot # 21a1102z for item # (b)(4) was reported by the emergency department that on three occasions the item broke in half when in use and in one case the product broke in the patient. Broken piece on speculum retrieved without injury to patient. On (b)(6) 2021:...show all
Additional Manufacturer Narrative: Welch allyn/hillrom is reporting this event in an abundance of caution. The actual vaginal speculum was not returned to welch allyn. This device is a manually inserted, disposable vaginal speculum. The root cause of these very rare failures was determined to likely be related to potential impacts or loads on...show all
Description of Event or Problem: Hillrom received a report from a the account that the vaginal speculum broke inside of a patient during a routine exam. There was no serious patient/user injury reported. This report was filed in our complaint handling system as complaint # (b)(4).
Additional Manufacturer Narrative: Welch allyn/hillrom is reporting this event in an abundance of caution. The actual vaginal speculum was not returned to welch allyn. This device is a manually inserted, disposable vaginal speculum. The root cause of these very rare failures was determined to likely be related to potential impacts, or loads on...show all
Description of Event or Problem: Hillrom received a report from a the account that the vaginal speculum broke inside of a patient during a routine exam. There was no serious patient/user injury reported. This report was filed in our complaint handling system as complaint # (b)(4).
Additional Manufacturer Narrative: Welch allyn/hillrom is reporting this event in an abundance of caution. The actual vaginal speculum was not returned to welch allyn. This device is a manually inserted, disposable vaginal speculum. The root cause of these very rare failures was determined to likely be related to potential impacts or loads on...show all
Description of Event or Problem: Hillrom received a report from a the account that the vaginal speculum broke inside of a patient during a routine exam. There was no serious patient/user injury reported. This report was filed in our complaint handling system as complaint #: (b)(4).
Additional Manufacturer Narrative: 3500a user facility report was received by mail from the fda. This report received indicated that a copy was sent to the manufacturer, however there was no complaint or copy of this report received from the user facility. There was no malfunction of the device, a selection is required for...show all
Description of Event or Problem: Patient was admitted for labor. The lighted speculum was utilized on the patient for a gynecological exam. During a separate exam a small firm piece of plastic consistent with the tab from lighted speculum was found in lower vagina and removed. This event poses a risk for a potential retained...show all
Description of Event or Problem: Patient was admitted for labor. The lighted speculum was utilized on the patient for a gynecological exam. During a separate exam a small firm piece of plastic consistent with the tab from lighted speculum was found in lower vagina and removed. This event poses a risk for a potential retained...show all
Additional Manufacturer Narrative: Ref: (b)(4). Investigation: x-inspect returned samples. Analysis and findings: a review of 2 year complaint history for the leep prima speculum large product #psv-2l shows similar complaints on file. The leep prima speculum large is a purchased product and it is not lot controlled. The leep prima speculum large was...show all
Description of Event or Problem: Chipped paint. Order: (b)(4). Reference: (b)(4).
Additional Manufacturer Narrative: The complaint condition reported is currently under investigation. A follow - up report will be filed once the investigation has been completed and the findings are available. (b)(4).
Description of Event or Problem: Chipped paint. Order: (b)(4).
Additional Manufacturer Narrative: (b)(4). Investigation: x-no sample returned. Analysis and findings: a review of the 2 year complaint history for the sani-scope disp anoscope shows 1 similar complaint. The sani-scope disp anoscope is a purchased item and not lot controlled . The last two shipments to sharp health care were made on 3/31/2011...show all
Description of Event or Problem: "i need to report an incident with one of your products. We currently use your sani-scope disposable anoscopes in our outpatient medical centers. We had an incident where the tip of the plastic plunger came off during an exam when the provider removed the plunger. Fortunately the tip was lodged...show all
Additional Manufacturer Narrative: Coopersurgical, inc. Is currently investigating the reported condition. Once the investigation is complete, a follow up report will be filed. (b)(4).
Description of Event or Problem: From new use, it conducted electricity and burned patient's vaginal wall (loss of coating on one side...).
Additional Manufacturer Narrative: Coopersurgical, inc. Is currently investigating the reported condition. Once the investigation is complete, a follow up report will be filed. (b)(4).
Description of Event or Problem: Issues with electricity which resulted in patient's vaginal wall burn.
Additional Manufacturer Narrative: Coopersurgical, inc is currently investigating the reported condition. Once the investigation is complete, a follow up report will be filed.
Description of Event or Problem: "obturator tip has come apart inside of patients rectum and has to be removed by doctor causing great discomfort on more than one occasion and not just the lot number above."
Description of Event or Problem: Speculums shatter very easily, one broke while using on patient and found packages with damage speculum which had to be discarded.
Additional Manufacturer Narrative: A (b)(6) week pregnant patient presented to the ob unit for observation with complaints of vaginal discharge and discomfort. A pelvic exam was started using a wa kleenspec vaginal speculum with a sheath. A wet and std swab were obtained., both were negative. At 22:05 the patient presented with swelling...show all
Description of Event or Problem: Welch allyn received a report from a welch allyn customer stating that they used a welch allyn vaginal speculum on a patient with a known latex allergy and she experienced an anaphylaxis reaction. This report was filed in our complaint handling system as complaint (b)(4).
Description of Event or Problem: Pt was having a vaginal exam using speculum. Top piece of speculum broke at base. Top piece removed from vaginal canal without injury or incident. Each speculum comes in individual package. Lot no: 17qb5793. Reorder #(b)(4), exp 11/30/2020, mfr - medline.
Additional Manufacturer Narrative: The 59004 large vaginal speculum involved in the event was returned to welch allyn for engineering evaluation along with 5 unused vaginal specula still sealed the polybag. Welch allyn engineering determined the lower bill break to a very clean break with no sharp edges or stress cracks. The damaged speculum...show all
Description of Event or Problem: A welch allyn sales representative in the (b)(6) informed welch allyn customer care that a 59004 kleenspec large disposable vaginal speculum broke inside a patient during an examination. A photo of the broken vaginal speculum involved in the event indicated that approximately 0.5 inch of the leading edge of the...show all
Additional Manufacturer Narrative: The 59004 large vaginal speculum involved in the event was returned to welch allyn for engineering evaluation along with 5 unused vaginal specula still sealed in a polybag. Welch allyn engineering determined the lower bill break to be a very clean break with no sharp edges or stress cracks. The...show all
Description of Event or Problem: A welch allyn sales representative in the (b)(4) informed welch allyn customer care that a second 59004 kleenspec large disposable vaginal speculum broke inside a patient during an examination. This second vaginal speculum broke the day after the first reported break and is from the same customer, lot, and box...show all
Additional Manufacturer Narrative: The customer did not provide a lot number therefore welch allyn was unable to review the device history record for the speculum. As the device and packaging was disposed of by the user we were unable to determine if this was a single rail or double rail speculum. Fourteen representative...show all
Description of Event or Problem: Welch allyn received a report stating, kleenspec 590 series disposable vaginal speculum broke while being used on a patient during a pelvic exam. The speculum was examined by the physician prior to use and no visible cracks were noted. The physician inserted the speculum into the patient's vagina and immediately...show all
Description of Event or Problem: Md was completing a pelvic exam. As md attempted to remove the speculum from the patient, the speculum cracked, a piece of plastic broke off, and the piece flew into the md's right eye. Md was treated for a corneal abrasion. Mfr name: (b)(4).
Description of Event or Problem: During a leep procedure, the pt was somehow burned. Instruments involved included: sklar lateral retractor #(b)(4), euro-med vaginal speculum #(b)(4), euro-med tenaculum #(b)(4).
Description of Event or Problem: "a number of the disposable anoscopes have broken at the tip while in use (during removal from patient)." (b)(4).
Description of Event or Problem: The dr. Was performing a vaginal exam and inserted the speculum without difficulty and attempted to open the speculum and it broke at the clear u shaped piece. Another exam was attempted with a new speculum and it broke in the same area.
Additional Manufacturer Narrative: Welch allyn is reporting this in an abundance of caution. The customer did not return the device that broke in use to welch allyn as the device was discarded. The customer did take a photograph of the actual device that broke in use. The photograph was reviewed by welch allyn...show all
Description of Event or Problem: A customer informed welch allyn of a vaginal speculum break in a patient during a pelvic exam. When the speculum was opened the lower part of the speculum broke into two pieces lengthwise. The larger part of the speculum was removed but the smaller piece of the speculum with a...show all
Description of Event or Problem: Customer stated that lower blade of speculum broke in use during a pt vaginal examination. The physician was able to remove the speculum without causing any harm or injury to the pt.
Additional Manufacturer Narrative: Welch allyn is reporting this in an abundance of caution. The actual speculum involved in the incident was returned and evaluated by welch allyn. The speculum was evaluated by engineering, and the failure mode matches the one that was previously investigated. The root cause of these very rare failures was...show all
Description of Event or Problem: Welch allyn received an email from a distributor that a doctor was performing a gyn procedure and the vaginal speculum broke in the patient's vagina. The break caused a superficial laceration in the patient's vagina. The patient did not require any medical treatment and is fine.
Additional Manufacturer Narrative: Welch allyn is reporting this in an abundance of caution. The actual speculum involved in the incident was returned and evaluated by welch allyn. The speculum was evaluated by engineering, and the failure mode matches the one that was previously investigated. The root cause of these very rare failures was...show all
Description of Event or Problem: A customer informed welch allyn of a vaginal speculum break in a patient. The doctor was using a medium speculum in a patient. When the speculum opened, the locking mechanism failed and the patient felt immediate pain. The doctor noticed that the bill of the speculum cracked down the middle...show all
Additional Manufacturer Narrative: Welch allyn is reporting this in an abundance of caution. The customer did not return the device that broke in use to welch allyn as the device was previously discarded. The customer did return a damaged device to welch allyn, discovered before use, with the same break pattern as the...show all
Description of Event or Problem: Clinician inserted a vaginal speculum into patient and noticed it was not opening normally. The speculum broke in patient with no sound of breaking plastic. The clinician noticed a broken piece of speculum upon removal from which the patient received a 1cm abrasion. F/u with the clinician indicated the patient...show all
Additional Manufacturer Narrative: Welch allyn is reporting this is an abundance of caution. The returned vaginal speculum was evaluated by welch allyn engineering. The failure mode matched one that has been previously investigated and was determined to be related to damage sustained from shipping and handling. No further investigation will be performed. Evaluation...show all
Description of Event or Problem: Speculum cracked and broke during exam resulting in abrasion to pt's vaginal cavity.
Description of Event or Problem: Welch allyn distributor informed welch allyn of a customer who had a vaginal speculum break in the patient and claims injury. On (b)(6) 2014 the emergency room physician performed a routine pap smear test on (b)(6) patient. Upon opening the speculum, the bill broke in half. The physician removed the...show all
Additional Manufacturer Narrative: Welch allyn is reporting this in abundance of caution. The customer did not return the device to welch allyn, but completed a questionnaire with a drawing of a vaginal speculum device indicating the break location and manner in which the vaginal speculum broke. The questionnaire and marked-up picture was reviewed...show all
Description of Event or Problem: A welch allyn distributor informed welch allyn of a customer who stated that a vaginal speculum broke while being used on a patient during a gyn exam and lacerated the patient's vagina. On (b)(6) 2014 the patient came in for a routine pap smear test. When attempting to remove the...show all
Additional Manufacturer Narrative: Welch allyn is reporting this is an abundance of caution. The customer disposed of the device, but provided pictures of the actual device to welch allyn for review. Pictures of the vaginal speculum were examined by engineering, and the failure mode matches one that has been previously investigated. The root...show all
Description of Event or Problem: The customer stated that a vaginal speculum broke being used on a patient during a gyn exam and lacerated the patient's vagina. The lower bill broke resulting in a sharp edge that caused a small superficial laceration to the cervix, approximately 1/4 inches in length with some bleeding noted. The...show all
Additional Manufacturer Narrative: Welch allyn is reporting this in an abundance of caution. The actual speculum involved in the incident was returned and evaluated by welch allyn. The speculum was examined by engineering, and the failure mode matches one that has been previously investigated. The root cause of these very rare failures was...show all
Additional Manufacturer Narrative: Welch allyn is reporting this in an abundance of caution. The actual speculum involved in the incident was returned and evaluated by welch allyn. The speculum was evaluated by welch allyn. The speculum was examined by engineering, and the failure mode matches one that has been previously investigated. The root...show all
Description of Event or Problem: The customer stated that the vaginal specula broke while being used on a patient during a gyn exam and lacerated the patient's vagina. Per the health care provider, the laceration was small, less than 1cm in length within the vagina. Bleeding was stopped with pressure - no suture needed. The...show all
Description of Event or Problem: Physician was performing an annual gynecological examination; upon trying to locate patient's cervix and applying necessary pressure to perform examination, the piece used to open the speculum broke.
Description of Event or Problem: The customer stated that a small sized speculum had broken during a routine exam. The customer stated that the speculum was inserted into a pt and the bottom bill broke; the pt was not injured. The customer did not provide a pt identifier.
Additional Manufacturer Narrative: Welch allyn is reporting this in an abundance of caution. The actual speculum involved in the event will not be returned to welch allyn. However, the complainant did provided a photograph of the broken speculum. The failure mode as described by the photograph has been previously investigated. The root cause...show all
Description of Event or Problem: The customer stated that a medium sized speculum had broken during a routine exam. The customer states that the speculum was inserted into a pt and the bottom bill broke into two pieces; the pt was not injured. The customer did not provide a pt identified.
Additional Manufacturer Narrative: Welch allyn is reporting this in an abundance of caution. The actual speculum was not returned to welch allyn. This device is a manually inserted, disposable vaginal speculum. The root cause of these very rare failures was determined to be related to potential impacts or loads on the shipping containers...show all
Description of Event or Problem: The customer stated that a small sized speculum had broken during a routine exam. The customer stated that the speculum was inserted into a pt and the bottom bill broke; the pt was not injured. The customer did not provide a pt identifier.
Additional Manufacturer Narrative: Welch allyn is reporting this in an abundance of caution. The actual speculum was returned to welch allyn. Welch allyn engineering evaluated the device and confirmed a lower bill break. This device is a manually inserted, disposable vaginal speculum. The root cause of these very rare failures was determined to...show all
Description of Event or Problem: The customer stated that a medium sized speculum had broken during a procedure. The customer states that the speculum was inserted into a patient and broke during use. When the item broke the patient sustained a cut. There was slight bleeding from the cut, however the patient did not require...show all
Additional Manufacturer Narrative: Welch allyn is reporting this in an abundance of caution. The device evaluation is not yet complete. A follow-up report will be submitted when the evaluation is complete.
Additional Manufacturer Narrative: Welch allyn is reporting this in an abundance of caution. The actual speculum involved in the event will not be returned to welch allyn. However, the complainant did provide a photograph of the broken speculum. The failure mode as described by the photograph has been previously investigated. The root cause...show all
Description of Event or Problem: The customer stated that a medium sized speculum had broken during a procedure. The customer states that the pt suffered a laceration to the vaginal wall, the area was cleansed and pt went home and was told to f/u as needed. The broken piece was removed and no suturing was...show all
Description of Event or Problem: The customer stated that during a pelvic exam with plastic speculum, upon opening for visualization of the cervix the lower portion of the speculum broke. This caused an abrasion to the labia. The abrasion did not require treatment and the pt is fine. The customer did not provide a pt...show all
Additional Manufacturer Narrative: Welch allyn is reporting this in an abundance of caution. The actual speculum was not returned to welch allyn. The customer confirmed the lower bill broke during an examination. This device is a manually inserted, disposable vaginal speculum. The root cause of these very rare failures was determined to be...show all
Additional Manufacturer Narrative: Welch allyn is reporting this is an abundance of caution. The actual speculum was returned to welch allyn. An engineering analysis of the speculum revealed the same failure mode as previously investigated on fi. This device is a manually inserted, disposable vaginal speculum. The root cause of these very rare...show all
Description of Event or Problem: During a procedure, the physician inserted the small sized speculum, spread the blades open and immediately heard a snap. The lower blade cracked and broke off inside the pt's vagina. The physician successfully removed the broken speculum from the pt. The pt had been uncomfortable prior to the exam, and...show all
Additional Manufacturer Narrative: Welch allyn is reporting this in an abundance of caution. Unused product was returned for eval, however, the actual speculum involved in the event has been disposed of by the customer and therefore will not be returned to welch allyn. However, the complainant did provide a photograph of the broken...show all
Description of Event or Problem: Beginning a procedure, the physician inserted the medium sized speculum. While inserting the specula, the clinician heard a pop. The physician noticed a broken piece of the lower blade while removing the speculum from the pt. The pt was uninjured. The customer did not provide a pt identifier.
Additional Manufacturer Narrative: Welch allyn is reporting this in an abundance of caution. Unused product was returned for eval, however, the actual speculum involved in the event has been disposed of by the customer and therefore will not be returned to welch allyn. However, the complainant did provide a photograph of the broken...show all
Description of Event or Problem: The customer stated that an add'l medium sized speculum had broken during a procedure. The customer states that lower blade had cracked. The pt was uninjured. The customer did not provide a pt identifier.
Additional Manufacturer Narrative: This device has not been returned to welch allyn for evaluation. We are submitting this report in an abundance of caution. A follow-up report will be submitted when the evaluation is complete.
Description of Event or Problem: During a procedure to remove an iud, the health care provider inserted the medium sized speculum, spread the blades open and locked them in place. Seconds after locking the speculum, the first inch and a half of the top blade cracked and broke off inside the patient's vagina. The patient...show all
Description of Event or Problem: Complainant stated that during a vaginal exam, the doctor inserted a medium sized speculum and directly upon opening the speculum, he heard a loud noise and the speculum broke in the pt's vagina. The doctor was able to remove the broken pieces without incident. The pt was not injured. The...show all
Additional Manufacturer Narrative: The speculum involved in the event was not returned to welch allyn for evaluation. However, the complainant did provide a photograph of the broken speculum along with two damaged speculums found prior to use. Engineering evaluated the photographs and confirmed the failure mode as a broken lower bill. The two...show all
Description of Event or Problem: Complainant stated that during an exam/during use inside a patient, a portion of the lower bill broke off inside the patient. The doctor was able to remove the piece without scratching the patient or causing any injury. The customer did not provide a patient identifier.
Additional Manufacturer Narrative: Welch allyn is reporting this event pursuant to fda's two-year reporting rule based on the original report filed on (b)(4) 2010. This speculum has been disposed of by the customer and therefore will not be returned to welch allyn. The failure mode as described by the complainant has been previously...show all
Description of Event or Problem: Complainant stated that the lower bill of the speculum broke longitudinally during an external examination and the pt sustained a small cut that was bleeding. Complainant stated that the pt did not require any intervention to stop the bleeding. She gave the pt topical lidocaine for the discomfort. The pt...show all
Additional Manufacturer Narrative: Welch allyn is reporting this event pursuant to fda's two-year reporting rule based on the original report filed on october 26, 2010. This speculum has not been returned to welch allyn. However, the complainant did provide welch allyn a photograph of the speculum. This failure mode is currently under evaluation...show all
Description of Event or Problem: Complainant stated the lower bill of a small vaginal speculum broke during use. When the physician removed the two pieces that remained in the pt, the pieces were sharp and a laceration of the vaginal wall resulted. The physician could not visualize the laceration due to bleeding and removed the...show all
Additional Manufacturer Narrative: Welch allyn is reporting this event pursuant to fda's two-year reporting rule based on the original report filed on (b)(4) 2010. This speculum has been discarded and has not been retuned to welch allyn. This failure mode is currently under eval and a follow-up report will be submitted when the...show all
Description of Event or Problem: The complainant stated that on (b)(6) 2011 during a pelvic exam, the pt complained of a "pinching" feeling. The complainant removed the small vaginal speculum and noted that the bottom bill was broken in a v shape and was very sharp. The speculum was all together, no pieces were missing....show all
Additional Manufacturer Narrative: Welch allyn is reporting this event pursuant to fda's two-year reporting rule based on the original report filed on october 26, 2010. This speculum has been discarded and has not been returned to welch allyn. This failure mode is currently under evaluation and a follow-up report will be submitted when...show all
Description of Event or Problem: The complainant stated that on (b)(6) 2012, a small vaginal speculum broke during a pelvic exam. The nurse practitioner inserted the speculum and when she opened the speculum, the bottom bill broke into three pieces, two pieces inside the patient and the speculum. The patient did receive a small cut....show all
Additional Manufacturer Narrative: Welch allyn is reporting this event pursuant to fda's two-year reporting rule based on the original report filed on (b)(4) 2010. This speculum has been returned to welch allyn and is currently under evaluation. A follow-up report will be submitted when the evaluation is complete.
Description of Event or Problem: (b)(6) from the (b)(6) dept of health and environmental control reported on form fda 3500 that on 2 incidents, (b)(6) 2012, our medium vaginal speculum product malfunctioned. The incidents consist of inserting the product into the vagina, after which a small piece of plastic broke off the speculum as the...show all
Additional Manufacturer Narrative: (b)(4) devices from old lot number (22909 from (b)(4)) and (b)(4) devices from new lot number (23717, from same company) were tested in a simulated use technique. All devices did not fail or break. We have sent a f/u letter and 2 reminders. Unfortunately , (b)(6) has not cooperated with...show all
Description of Event or Problem: After the speculum was inserted into the vagina, small piece of plastic broke off of the speculum as the nurse was beginning to open the speculum in the vagina. This occurred on (b)(6) 2012. She was hit on the chin during one occurrence and on the cheek during the other...show all
Additional Manufacturer Narrative: This device has not been returned to welch allyn for evaluation. A follow-up report will be submitted when the evaluation is complete.
Description of Event or Problem: Complainant stated that a medium sized disposable vaginal speculum broke when inserted into the pt. Complainant described the break on the bottom bill and a piece came off, leaving a sharp edge. The physician was able to remove the speculum and piece without incident or injury. The customer did not...show all
Description of Event or Problem: Kleenspec vaginal specula illumination system was used as a light source for illumination without the plastic speculum. The light bulb becomes warm, to hot to the touch at the tip of the bulb while the sides remain cool to touch providing no indication the bulb gets as hot as it...show all
Description of Event or Problem: During a routine ob pelvic examination of a 38 week pregnant pt, the medium size disposable vaginal speculum broke. The physician had inserted the speculum as normal and when he clicked the speculum open, he heard a snap and the speculum broke into 2 pieces. He closed the speculum and...show all
Additional Manufacturer Narrative: This device has not been returned to welch allyn for eval. A follow-up report will be submitted when the eval is complete.
Description of Event or Problem: During a vaginal examination, the lower blade of the speculum broke creating a sharp, pointed edge and lacerated the pt's right vaginal wall. The condition of the pt is unknown at this time. This event was reported to the fda by the complaint. The customer did not provide a pt...show all
Additional Manufacturer Narrative: This device has not been returned to welch allyn for evaluation. A follow-up report will be submitted when the evaluation is complete.
Description of Event or Problem: Complainant stated: the open/close mechanism of the 6550 vaginal speculum broke during a pt exam. The open/close mechanism was located outside of the pt. There were no injuries and no medical intervention was needed. This event occurred in (b)(6).
Additional Manufacturer Narrative: Investigation could not be performed as product was discarded by user. Lot number could not be confirmed for batch review. Defect could not be confirmed. There have been no other complaints of this type for this product.
Additional Manufacturer Narrative: The returned leep vu_max large speculum was thoroughly investigated by our service and repair department. The investigation revealed the coating insulating properties were intact. The returned unit was put through a hi-pot test and passed. Visual examination revealed the coating was scratched, but functional and within specification. Although there is...show all
Description of Event or Problem: Pt felt burn sensation at operative site.
Additional Manufacturer Narrative: This device was rec'd by welch allyn and is currently under eval. A f/u report will be submitted.
Description of Event or Problem: The physician inserted a small disposable vaginal speculum to perform a pelvic exam and upon opening the speculum, the speculum bottom bill broke. The physician removed the broken speculum and unsuccessfully attempted to insert another speculum to visualize the retained piece. After failing to insert another speculum, the physician manually...show all
Description of Event or Problem: Welch ally became aware of this event via medwatch report (b)(4). During a vaginal exam for complaint of vaginal discharge, physician assistant (pa) discovered after removing the speculum that it had a piece fractured off longitudinally on one side. The pa did a manual sweep of the vaginal vault to...show all
Additional Manufacturer Narrative: Method: the actual devices have not been returned to welch allyn for evaluation. Complainant provided photographic evidence of break. Results: vaginal speculum.
Description of Event or Problem: During vaginal exam for complaint of vaginal discharge, physician's assistant discovered after removing the speculum that it had a piece fractured off longitudinally on one side. the edge that was fractured did not appear very sharp suggesting the piece may have broken off during manufacturing? the patient had...show all
Additional Manufacturer Narrative: The actual devices have not been returned to welch allyn for evaluation. Results: vaginal speculum.
Description of Event or Problem: Speculum used for pap smear spontaneously broke (one arm cracked with sharp point) causing small laceration to pt with small amount of bleeding. Speculum had not been dropped or otherwise injured, did not appear abnormal before insertion. The customer did not provide a pt identifier.
Description of Event or Problem: Welch allyn rec'd a report from a distributor of an incident involving a 59001 vaginal speculum. During a pelvic examination, the physician heard the 590 medium sized vaginal speculum break upon the second click while opening the speculum. The bottom lip of the speculum broke into two separate pieces from...show all
Additional Manufacturer Narrative: Method: the actual devices have not been returned to welch allyn for eval but photographic evidence was provided. Results: vaginal speculum.
Description of Event or Problem: Speculum used for pap smear spontaneously broke (one arm cracked with sharp point) causing small laceration to patient with small amount of bleeding. speculum had not been dropped or other wise injured, did not appear abnormal before insertion.
Additional Manufacturer Narrative: The actual devices have not been returned to welch allyn for eval. Results: vaginal speculum.
Description of Event or Problem: Welch allyn became aware via medwatch report (b)(4) that during a pelvic exam, the vaginal speculum shattered into 3 pieces while still in the pt. Doctor was able to manually remove speculum shard pieces without injury to pt or left over shards in cervix, vaginal orifice, or labias. The customer...show all
Additional Manufacturer Narrative: The actual devices have not been returned to welch allyn for eval. Vaginal speculum.
Description of Event or Problem: A customer reported welch allyn vaginal speculums cracked in two pts and a total of six speculums were cracked out of their box of twenty four. The clinician noticed one speculum that had a little crack in it when the physician took it out of storage. Neither pt was aware...show all
Description of Event or Problem: Welch allyn became aware through (b)(4) that a vaginal speculum broke during a pelvic examination on a (b)(6). There was a small laceration (less than 1mm) and some minor bleeding. The pt is fine and did not require any medical attention.
Additional Manufacturer Narrative: Method: the actual device has not been returned to welch allyn for eval. Results - vaginal speculum.
Description of Event or Problem: Plastic speculum broke while inside patient, minor bleeding less than 1 ml. Patient 33 weeks pregnant.
Description of Event or Problem: The customer indicated that while performing a vaginal exam on a pregnant patient (28 weeks gestation), the physician inserted a medium sized speculum and when she pushed down on the piece to open the speculum, the bottom blade broke, causing a laceration to the left vaginal wall. The patient was...show all
Additional Manufacturer Narrative: Method: the actual device has not been returned to welch allyn for evaluation. Results: vaginal speculum.
Additional Manufacturer Narrative: Method - the actual device was returned to welch allyn and is currently under evaluation. Results - vaginal speculum.
Description of Event or Problem: Complainant stated that on (b)(6) 2010 during insertion of a medium sized disposable speculum, the bottom bill snapped, leaving jagged edges. Two superficial lacerations to the vaginal wall with a small amount of bleeding was immediately noted. The broken speculum was removed. A metal speculum was inserted and the exam...show all
Description of Event or Problem: Welch allyn received a complaint in which the lower bill a vaginal speculum broke during an pap examination. The physician removed the broken speculum from the pt without incident. There was no injury to the pt. The customer did not provide a pt identifier. This event occurred in (b)(6).
Additional Manufacturer Narrative: Method: actual device involved in incident was discarded by the complainant and not available for evaluation by welch allyn. Results: vaginal speculum.
Description of Event or Problem: Welch allyn received a complaint that during an examination a pt experienced discomfort as a result of specula breaking spontaneously while inside vagina. No injury was reported related to this event. The customer did not provide a pt identifier.
Additional Manufacturer Narrative: The actual device was returned to welch allyn and is currently under evaluation. Results code: vaginal speculum.
Description of Event or Problem: Welch allyn received a complaint in which the lower bill a vaginal speculum broke during an examination. The physician removed the broken speculum from the pt without incident. There was no injury to the pt. The customer did not provide a pt identifier.
Additional Manufacturer Narrative: Method: actual device involved in incident was discarded by the complainant and not available for evaluation by welch allyn. Results: vaginal speculum.
Description of Event or Problem: During a pelvic exam, the vaginal speculum (b)(4) shattered into 3 pieces while still in patient. Dr (b)(6) was able to manually remove speculum shard pieces without injury to patient or left over shards in cervix, vaginal orifice, or labias. Diagnosis or reason for use: abdominal pain needing a pelvic...show all
Description of Event or Problem: Welch allyn became aware of an incident where a female pt received a 1 cm wound on the right lateral wall of her vagina after the vaginal spec broke in half longitudinally along the blade during a pelvic exam. Pt was prescribed antibiotics and percocet. The customer did not provide...show all
Additional Manufacturer Narrative: The actual device is currently under eval by welch allyn. Eval, results: vaginal speculum.
Description of Event or Problem: Physician note states, "during the course of the pelvic exam, the blade on the plastic speculum broke in half longitudinally along the blade. This created a sharp hook on the piece of the blade that broke off and was in the vagina. It caused a wound along the right lateral...show all
Description of Event or Problem: Welch allyn became aware of an incident where a female patient was injured while undergoing an examination when the bottom piece of the kleenspec disposable vaginal speculum broke diagonally along the lower bill. The patient received a laceration to the lateral vaginal wall and required sutures as a result of...show all
Additional Manufacturer Narrative: Welch allyn contacted the complainant for additional information. The complainant stated while lifting the vaginal wall for visualization the bottom bill broke in a jagged, longitudinal line. The vaginal speculum was pulled out by the handle and the broken piece remained. A lateral vaginal wall laceration was caused when the...show all
Description of Event or Problem: Broken disposable (plastic speculum) while being introduced to the pt for care. Manufacturer: medline. Manufacturer #: (b)(4). Lot #: o9ja0451. Quantity: 12ea (all pulled from stock). (b)(4). On (b)(6)2010, staff at occupation health dept performed a procedure utilizing a disposable vaginal speculum. When performing procedure on the pt, the speculum...show all
Description of Event or Problem: Welch allyn became aware of an incident, (b)(4), that while a female pt was undergoing an examination, the bottom piece of the kleenspec disposable vaginal speculum broke in half diagonally. The broken portion was removed by the physician. The speculum did not appear to be cracked or broken when it...show all
Additional Manufacturer Narrative: Actual device involved in incident was evaluated through photographic images taken by the complainant and supplied to welch allyn. Pictures of the device were supplied by the complainant. The actual device is being returned for eval but has not yet been received by welch allyn. Device failure directly cause the...show all
Description of Event or Problem: The vaginal speculum had been inserted and as the physician opened it, it broke apart leaving sharp edges inside the patient's vagina. the physician removed the speculum and did not observe any injuries to the patient. the speculum did not appear cracked and was not broken when the...show all
Description of Event or Problem: Welch allyn received a call on (b) (6) 2010, from the customer's/complainant's facility indicating that while a female pt was undergoing a gynecological examination (pap test) the bottom piece of the kleenspec disposable vaginal speculum broke in half diagonally. The upper portion of the speculum was removed immediately however, the...show all
Additional Manufacturer Narrative: Actual device involved in incident was evaluated through photographic images taken by the complainant and supplied to welch allyn. Conclusions: pictures of the device were supplied by the complainant. The actual device is being returned for evaluation, but has not yet been received by welch allyn.
Description of Event or Problem: Pt was undergoing a pap test. The plastic speculum was inserted in a normal fashion. The speculum was opened intra-vaginally. At this time, the bottom portion split diagonally in two. The upper portion was removed immediately, leaving a plastic part approximately 5cm long. Any attempts to remove it, were complicated...show all
Description of Event or Problem: Speculum broke inside patient after it was inserted, and nurse practitioner tried to open it; speculum removed without injury; no patient harm.
Description of Event or Problem: Welch allyn received a user facility report on 12/15/2009, indicating that a nurse accidentally used a vaginal spec illuminator as a transilluminator during a peripheral intravenous catheter start, inadvertently causing 2nd-degree burns to the palm and forearm of the pt. The nurse indicated that he intended to use a different...show all
Additional Manufacturer Narrative: Welch allyn received uf report on 12/15/2009 detailing this event. We contacted the user facility to determine if they were sending us the device for eval. They were not sending us the device. The user facility's rep confirmed that 2nd-degree burns resulted to the pt. The device was not used...show all
2009-01-06 WELCH-ALLYN(No full report available)
Description of Event or Problem: After exam, it was noted that the patient was bleeding slightly. Physician examined speculum and found that a piece was cracked and broken off, still in packaging. Speculum is clear and this crack was not evident at beginning of exam. Diagnosis: pelvic exam. Event abated after use stopped or dose...show all
2008-10-24 ALLEGIANCE DISPOSABLE VAGINAL SPECULUM(No full report available)
Description of Event or Problem: Several providers in our family medicine clinic have reported failures with disposable vaginal specula during examinations. The specula crack and shatter during examinations. There have been approx 10 occurrences of device failure over the past 45 days. No injuries have been reported though the shattered plastic has almost struck providers...show all
2008-08-18 WELCH ALLYN KLEENSPEC(No full report available)
Description of Event or Problem: Patient had come in for a yearly pap smear. The speculum was introduced into the vagina and samples taken. When the speculum was removed, it had split at the bottom from the handle outward causing the patient severe pain and discomfort as well as cutting and pinching of the internal...show all
2007-06-01 MCKESSON(No full report available)
Description of Event or Problem: Nurse practitioner was conducting a vaginal exam using the mckesson brand speculum. During the exam, the speculum broke cutting the pt's vaginal wall.
Additional Manufacturer Narrative: Attempts to gain add'l info concerning this event has not yet yielded any results. Upon receipt of any add'l info, this report may be supplemented as needed.
2006-03-02 WELCH ALLYN DISPOSABLE VAGINAL SPECULUM(No full report available)
Description of Event or Problem: Vaginal speculum broke while opening it, internal to the pt. The break occurrred on a portion of the device that was external to the pt. There was no adverse event. There was no injury to the pt.
2006-03-02 WELCH ALLYN DISPOSABLE VAGINAL SPECULUM(No full report available)
Description of Event or Problem: Clinician noticed an unopened and unused vaginal speculum in storage which was cracked.
2006-01-04 KLEENSPEC DISPOSABLE VAG. SPEC. (MEDIUM)(No full report available)
Description of Event or Problem: Vaginal speculum broke in situ. Patient was not injured. No intervention required.
2005-11-10 WELCH ALLYN(No full report available)
Additional Manufacturer Narrative: Device has not yet been returned to manufacturer for evaluation. Return authorization was granted to retrieve product, (b)(4). Without direct failure analysis on the part, no conclusion can be drawn at this time. (b)(4) r.a. Engineer called initial reporter on (b)(4) 2005, and left voice mail message to return call....show all
Description of Event or Problem: Vag speculum was in situ, the speculum suddenly broke at the bottom, "on the tongue part" (blade). The patient got a nick, not requiring stitches, but it did bleed a little. No intervention required.
2005-10-31 KLEENSPEC 580 SERIES, LARGE(No full report available)
Additional Manufacturer Narrative: Device was discarded by user, no evaluation possible.attached note:this is a re-submittal. Original 3500a did not have a complete mfr report #. Sory for any inconvenience. 10/31/05.
Description of Event or Problem: During use of vaginal speculum, it broke when in situ. This lead to a small laceration to the patient's vaginal wall. No intervention required.
2005-10-04 KLEENSPEC 580 SERIES, LARGE(No full report available)
Additional Manufacturer Narrative: Device was discarded by user. No evaluation possible.
Description of Event or Problem: During use of vaginal speculum, it broke when in situ. This led to a small laceration to the patient's vaginal wall. No intervention required.
2005-07-21 KLEENSPEC 580 SERIES, MEDIUM(No full report available)
Description of Event or Problem: During use of vaginal speculum, it broke when in situ. This led to a small laceration to the patient's vaginal wall.
Additional Manufacturer Narrative: Device was discarded by user, no evaluation possible. Two other unused devices from the same box were found to be broken as stored at the practice.
2005-05-17 KLEENSPEC(No full report available)
Description of Event or Problem: Nurses were having trouble locating a vein on an patient and asked the nursing supervisor for a lamp to illuminate the veins. the supervisor borrowed a lamp from the emergency department that is used with speculums and is very bright. the lamp was held under the patients hand...show all
2005-03-02 GRAVES SPECULUM (MED. AND LGE)(No full report available)
Description of Event or Problem: The plastic handle on 1 medium and 1 large sterile speculum broke off in rptr's hand during insertion with minimal pressure applied.
2005-02-16 KLEENSPEC 580 SERIES DISPOSABLE VAGINAL SPECULUM, MEDIUM(No full report available)
Description of Event or Problem: Vaginal speculum broke off in pt. No injury alleged.
2004-12-07 EXPANDAVIEW(No full report available)
Description of Event or Problem: During a vaginal examination, a plastic speculum was reported to have broken in the pt.
2004-12-01 DISPOSABLE VAGINAL SPECULA(No full report available)
Description of Event or Problem: A disposable specula broke during a pelvic exam. The speculum was removed and then the broken part was removed. Patient was bleeding. The exam was halted.
Additional Manufacturer Narrative: Device is available for evaluation at the customer sight. Evaluation has not been conducted at time of this report.
2004-10-29 KLEENSPEC VAGINAL SPECULAR(No full report available)
Additional Manufacturer Narrative: The device involved in the reported event was returned to welch allyn, inc. For evaluation. It was determined that a molded piece of the device was slightly out of specifications causing the part to bind. The problem was traced to two specific cavities within the multiple part injection molds. The...show all
Description of Event or Problem: Plastic vaginal specula stuck in the open position. Difficult to remove from patient.
2004-10-29 KLEENSPEC VAGINAL SPECULA(No full report available)
Description of Event or Problem: Plastic vaginal specula stuck in the open position. Difficult to remove from patient.
Additional Manufacturer Narrative: The device involved in the reported event was returned to welch allyn, inc. For evaluation. It was determined that a molded piece of the device was slightly out of specifications causing the part to bind. The problem was traced to two specific cavities within the multiple part injection molds. The...show all
2004-10-29 KLEENSPEC VAGINAL SPECULA(No full report available)
Additional Manufacturer Narrative: The device involved in the reported event was returned to welch allyn, inc. For evaluation. It was determined that a molded piece of the device was slightly out of specifications causing the part to bind. The problem was traced to two specific cavities within the multiple part injection molds. The...show all
Description of Event or Problem: Plastic vaginal specula stuck in the open position. Difficult to remove from patient.
2004-10-29 KLEENSPEC VAGINAL SPECULA(No full report available)
Description of Event or Problem: Plastic vaginal specula stuck in the open position. Difficult to remove from patient.
Additional Manufacturer Narrative: The device involved in the reported event was returned to welch allyn, inc. For evaluation. It was determined that a molded piece of the device was slightly out of specifications causing the part to bind. The problem was traced to two specific cavities within the multiple part injection molds. The...show all
2004-10-29 KLEENSPEC VAGINAL SPECULA(No full report available)
Description of Event or Problem: Plastic vaginal specula broke during use causing laceration of labia. There was minor bleeding that was stopped with application of silver nitrate.
Additional Manufacturer Narrative: The device involved in the reported event was returned to welcy allyn, inc. For evaluation. It was determined that one of the device's plastic expander components was broken into multiple pieces. However, no conclusion could be drawn as to why the component failed. Welch allyn, inc. Has reviewed the desgin...show all
2004-10-29 KLEENSPEC VAGINAL SPECULA(No full report available)
Description of Event or Problem: Plastic vaginal specula broke during use. No patient injury.
Additional Manufacturer Narrative: The device involved in the reported event was returned to welcy allyn, inc. For evaluation. It was determined that one of the device's plastic expander components was broken into multiple pieces. However, no conclusion could be drawn as to why the component failed. Welch allyn, inc. Has reviewed the design...show all
2004-10-29 KLEENSPEC VAGINAL SPECULA(No full report available)
Description of Event or Problem: Plastic vaginal specula broke during use. Minor scratch to patient's perineum.
Additional Manufacturer Narrative: The device involved in the reported event was returned to welcy allyn, inc. For evaluation. It was determined that one of the device's plastic expander components was broken into multiple pieces. However, no conclusion could be drawn as to why the component failed. Welch allyn, inc. Has reviewed the design...show all
2004-10-28 KLEENSPEC VAGINAL SPECULA(No full report available)
Additional Manufacturer Narrative: Device was never returned. Conclusions: device not returned for evaluation.
Description of Event or Problem: Plastic vaginal specula broke during use cause laceration.
2004-10-28 KLEENSPEC VAGINAL SPECULA(No full report available)
Description of Event or Problem: Plastic vaginal specula broke during use causing a laceration to vaginal wall not requiring intervention.
Additional Manufacturer Narrative: Device was not returned and no lot information is available. Conclusions: device not returned for evaluation.
2004-10-28 KLEENSPEC VAGINAL SPECULA(No full report available)
Description of Event or Problem: Plastic vaginal specula stuck in open position. Difficult to remove from patient.
Additional Manufacturer Narrative: Device not returned for inspection. Conclusions: device not returned for evaluation.
2004-10-28 KLEENSPEC VAGINAL SPECULA(No full report available)
Additional Manufacturer Narrative: Method: device not returned for eval. Discarded by user. Conclusions: device not returned for eval.
Description of Event or Problem: Plastic vaginal specula broke during use causing laceration.
2004-10-28 KLEENSPEC VAGINAL SPECULA(No full report available)
Additional Manufacturer Narrative: Method: device was discarded by user. Conclusions: device not returned for eval.
Description of Event or Problem: Plastic vaginal specula broke during use. No injury reported.
2004-06-15 KLEENSPEC(No full report available)
Description of Event or Problem: A vaginal speculum broke during a procedure causing internal scratches to a patient. The bottom broke creating edges on the remaining portion and pieces.
2004-06-02 KLEENSPEC VAGINAL SPECULA(No full report available)
Description of Event or Problem: Vaginal specula broke during a procedure causing internal scratches to the pt.
2004-02-25 KLEENSPEC(No full report available)
Description of Event or Problem: Small vaginal speculum would not close after opening during a procedure and had to be broken in order to remove it from the pt's vagina.
2004-02-24 CENTURION PELVIC EXAM TRAY(No full report available)
Description of Event or Problem: The speculum was inserted into the patient and opened to perform a pelvic exam. upon completion of the exam, the speculum would not close. the speculum was removed from the patient in the open position. after the speculum was removed from the patient, the care providers were...show all
2004-02-24 CENTURION PELVIC EXAM TRAY(No full report available)
Description of Event or Problem: A speculum was inserted into the patient for a pelvic exam. upon completion of the exam, the speculum was stuck in the open position and could not be closed. the speculum was removed from the patient in the open position.a similar event occurred with the same device from...show all
2003-10-15 WELCH-ALLYN SMALL SPECULUM(No full report available)
Description of Event or Problem: Smallspeculum would not disengage and had to be broken in order to remove it from the vagina.
2003-09-08 LEEP VU-MORE SPECULUM(No full report available)
Description of Event or Problem: During an electrosurgical procedure, the pt felt shocking sensations. There was no report of pt injury.
2003-08-20 WELCH ALLYN KLEENSPEC(No full report available)
Description of Event or Problem: Speculum will not close before removal. The barrel that holds the illuminator does not have the top casing, and this perhaps keeps the speculum from closing easily. The illuminator will not stay since the barrel for holding it is imcomplete. Reporter doesn't have to use the illuminator, however this device...show all
2003-08-06 WELCH-ALLYN SMALL SPECULUM(No full report available)
Description of Event or Problem: When speculum was opened - popped open and splashed back into rnp's face.
2002-12-03 WELCH ALLYN KLEENSPEC SPECULUM(No full report available)
Description of Event or Problem: Integrity of speculum compromised. Device broke on insertion into pt. After speculum inserted, upon opening, speculum broke and sharp piece inside vagina.
2002-11-14 KLEEN SPEC(No full report available)
Description of Event or Problem: Single-use vaginal speculum broke after insertion causing minor injury to vaginal wall. Some bleeding was noted which resolved itself spontaneously. The broken piece was removed from the vagina.
2002-11-12 KLEEN SPEC(No full report available)
Description of Event or Problem: Single-use vaginal speculum broke after insertion causing minor injury to vaginal wall. Some bleeding was noted which resolved itself spontaneously. The broken piece was removed from the vagina.
2002-10-09 WELCH ALLYN KLEENSPEC SPECULUM(No full report available)
Description of Event or Problem: After speculum inserted, upon opening - speculum broke with sharp piece inside vagina. Upper portion had to carefully manually remove piece in vagina.
2002-09-19 VAGINAL ILLUMINATION SYSTEM(No full report available)
Description of Event or Problem: In 02 vaginal light used for illuminating veins for needed for iv. Burns 2nd degree to palms and right foot.
2002-04-02 VAGINAL SPECULUM(No full report available)
Description of Event or Problem: During pap smear the vaginal speculum broke at the handle latch causing the top blade to snap shut.
2002-02-27 VAGINAL SPECULUM(No full report available)
Description of Event or Problem: During pap smear the vaginal speculum broke at the handle latch causing top blade to snap shut.
2002-02-05 DISPOSABLE VAGINAL SPECULUM(No full report available)
Description of Event or Problem: "speculum comes".
2001-10-02 DISPOSABLE SPECULUM(No full report available)
Description of Event or Problem: Speculum separated. Hard to get back together.
2001-10-02 *(No full report available)
Description of Event or Problem: Speculums falling apart - will not lock into place.
2001-09-07 PRIMA SPECULUM(No full report available)
Description of Event or Problem: Hosp reported 1.5" end of upper bill of heavy gauge plastic speculum broke during a procedure. The broken piece was manually (fingers or forceps) removed immediately. There was no pt injury.
2001-08-30 *(No full report available)
Description of Event or Problem: Defective speculum - small and medium size.
2001-04-09 *(No full report available)
Description of Event or Problem: Specula will not latch. Plastic seems weak - bends easily.
2000-02-14 *(No full report available)
Description of Event or Problem: Medline pap smear trays come with a medium speculum, that is unacceptable for use. The speculum is too short for most females. The main problem however is that the speculum, a few times has closed down on the cervix of a few women causing pain. The speculum also has broken...show all
2000-02-14 MEDIUM WELCH ALLYN SPECULUM(No full report available)
Description of Event or Problem: Plastic speculum "welch allyn" broke during exam resulting in superficial laceration with oozing which subsided with 60 secs of pressure. Will need re-check in 7-14 days.
1999-01-08 KLEENSPEC(No full report available)
Description of Event or Problem: Additional info received from the mfr on 02/18/1999: the fracture appears to have started at the inside surface of the lower blade and travels through to the outside. This is exactly in the opposite direction of any force application. Shipping tests and force tests have failed to produce this type...show all
1998-01-06 DISPOSO SPEC(No full report available)
Description of Event or Problem: Medwatch report sent on 12/12/97 rec'd on 12/16/1997. Medwatch report sent on 12/17/97. Rec'd on 1/5/98, with form 3500a (a-e part) co will fill out report and add section h which was not sent to co just the instructions.
1997-12-17 *(No full report available)
Description of Event or Problem: Vaginal speculums once inserted in the pt and locked in place, cannot be released. The locking mechanism becomes stuck, preventing the providers from releasing the locking mechanism to remove the speculum after the procedure is completed. It has taken up to five mins just to release the locking mechanism on...show all
1997-01-10 WELCH-ALLYN(No full report available)
Description of Event or Problem: Plastic vaginal speculum broke apart during pelvic exam leaving sharp portion of the device inside of the pt. Remaining piece caused small laceration to vaginal wall.
1996-05-24 VAGINAL SPECULUM(No full report available)
Description of Event or Problem: During a routine pap the lower blade of the speculum developed a linear crack in the center of the blade 6 cm long. There was no injury to pt.
1995-12-28 VAGINAL SPECULUM, PLASTIC, SMALL 5/8(No full report available)
Description of Event or Problem: Providers complained of speculums being short and they were difficult to lock properly during insertion. They were also very difficult to unlock after a pap procedure, increasing pt pain.