MAUDE Adverse Event Report: WELCH ALLYN KLEENSPEC 590 PREMIUM VAG SPEC LG CASE; KLEENSPEC DISPOSABLE VAGINAL SPECULA, LARGE

Model Number 59004

Device Problem Fracture (1260)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/16/2017

Event Type  malfunction  

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 specula was also returned with a broken thumb tab not noted in the complaint and was observed to have discoloration and cracks not consistent with unused specula and scuff marks on both upper and lower blades were observed in the middle of the blade length.Engineering noted some plastic discoloration typical of repeated chemical and or enclave use but also noted the vaginal speculum was decontaminated at welch allyn prior to the engineering evaluation that may have caused or contributed to finding.Note: customer noted vaginal specula was not cleaned or sterilized with anything prior to use.Customer noted speculum was single use.The 5 returned unused vaginal specula from the same lot were reviewed.Visual inspection of all 5 unused 59004 specula show scuff marks consistent with the vaginal speculum involved in event.All 5 of the unused 59004 vaginal specula were examined, under a 25x power microscope, for small hairline cracks.No cracks were observed on any of the 5 unused vaginal specula.A destructive test was performed to try to duplicate the customer complaint.A force of 29 lbs.Was determined to be the amount of force required to break the lower bill.This amount of force exceeds the minimum requirement of the 6 lbs.Force that is utilized in a test conducted at the time of manufacture as noted in the device history record.Based on the lot number of the device, it was determined that the date of manufacture was 2015-09-21.Review of the dhr for the speculum found the lot passed all release testing.A review of customer complaints determined this is the second occurrence of a lower bill break in use since (b)(6) 2010.Both occurrences from same customer over a 2 day period from the same lot and case.The directions for use and device packaging for the vaginal speculum both state "warning: if a speculum is damaged, do not use any specula from the same case." there have been no prior reported complaints for the 59004 vaginal specula, excluding the the two instances above.Sales since april 2010 show approximately (b)(4) devices sold.Based on this information, no further action is required.

Event Description

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 as reported on mdr 1316463-2017-00007.Both brakes occurred approximately 2 weeks prior to welch allyn awareness.Welch allyn sales representative identified the issue as a lower bill break.The broken piece was removed from the patient's vagina without incident and the patient was not injured.

• Brand Name: KLEENSPEC 590 PREMIUM VAG SPEC LG CASE
• Type of Device: KLEENSPEC DISPOSABLE VAGINAL SPECULA, LARGE
• Manufacturer (Section D): WELCH ALLYN; 4341 state street road; p.o. box 220; skaneateles falls NY 13153 0220
• Manufacturer Contact: edward o'neil ; 4341 state street road; p.o. box 220; skaneateles falls, NY 13153-0220
• MDR Report Key: 6678006
• MDR Text Key: 78789218
• Report Number: 1316463-2017-00008
• Device Sequence Number: 1
• Product Code: HIB
• UDI-Device Identifier: 00732094143652
• UDI-Public: 00732094143652
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K070964
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 59004
• Device Catalogue Number: 59004
• Device Lot Number: 20150921
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2017
• Date Manufacturer Received: 06/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/21/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other