MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2014-10-29 for KLEENSPEC 590 SERIES DISP. VAGINAL SPECULA 59001 manufactured by Welch Allyn, Inc..
[5075202]
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 speculum, it was noted to be stuck to the posterior wall of the vagina. The physician ran her fingers along the sides, in an attempt to release the suction. She also visualized the speculum internally and noted the bottom bill to have a vertical crack; the physician proceeded to snap the crack entirely to release the pressure and removed the speculum. The patient did sustain a laceration (size is undetermined) with bleeding noted. The patient was given instructions to return if any problems developed. No additional treatment was administered.
Patient Sequence No: 1, Text Type: D, B5
[12533280]
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 cause of these very rare failures was determined to be related to potential impacts or loads on the shipping containers during transit or storage. No further investigation will be performed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1316463-2014-00009 |
| MDR Report Key | 4235666 |
| Report Source | 01,07 |
| Date Received | 2014-10-29 |
| Date of Report | 2014-10-28 |
| Date of Event | 2014-10-07 |
| Date Mfgr Received | 2014-10-07 |
| Device Manufacturer Date | 2014-07-29 |
| Date Added to Maude | 2014-11-25 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | PEARLEY BHAMBRI, RA DIRECTOR |
| Manufacturer Street | 4341 STATE ST. RD. P.O. BOX 220 |
| Manufacturer City | SKANEATELES FALLS NY 131530220 |
| Manufacturer Country | US |
| Manufacturer Postal | 131530220 |
| Manufacturer Phone | 3156852568 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KLEENSPEC 590 SERIES DISP. VAGINAL SPECULA |
| Generic Name | VAGINAL SPECULA |
| Product Code | HIB |
| Date Received | 2014-10-29 |
| Model Number | 59001 |
| Catalog Number | 59001 |
| Lot Number | 237784 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WELCH ALLYN, INC. |
| Manufacturer Address | 4341 STATE ST. RD. SKANEATELES FALLS NY 13153 US 13153 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-10-29 |