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 was also 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 found that this is the first occurrence of a lower bill break in use since april 2010.There have been no prior reported complaints for the 59004 vaginal specula.Sales since april 2010 show approximately (b)(4) devices have been sold.Based on this information, no further action is required.
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