MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-11-09 for KLEENSPEC 580 SERIES DISP. VAGINAL SPECULA 58001S manufactured by Welch Allyn.
[2985115]
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 customer did not provide a pt identifier.
Patient Sequence No: 1, Text Type: D, B5
[10335239]
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 returned speculums were evaluated by engineering. One speculum had a cracked lower bill similar to those noted in a previous failure investigation and the other speculum had a scuff on the lower bill (no crack or break noticed). Both of the returned speculums were found by the complainant prior to use. This failure mode of the lower bill break in use has been previously investigated. The root cause of these very rare failures is believed to be related to atypical impacts or loads on the shipping containers during transit or storage. Method: (actual device not returned, photograph provided). Results: (vaginal speculum). Conclusion: (actual device not returned - confirmed shipping damage by visual evaluation).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1316463-2012-00012 |
| MDR Report Key | 2864560 |
| Report Source | 05,06 |
| Date Received | 2012-11-09 |
| Date of Report | 2012-10-09 |
| Date of Event | 2012-10-09 |
| Date Mfgr Received | 2012-10-09 |
| Date Added to Maude | 2013-02-15 |
| 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 | PEARLY BHAMBRI, 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 580 SERIES DISP. VAGINAL SPECULA |
| Product Code | HIB |
| Date Received | 2012-11-09 |
| Returned To Mfg | 2012-10-23 |
| Model Number | 58001S |
| Catalog Number | 58001S |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WELCH ALLYN |
| Manufacturer Address | 4341 STATE ST. RD. SKANEATELES FALLS NY 13153 US 13153 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-11-09 |