MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2013-09-04 for KLEENSPEC 590 SERIES DISP VAGINAL SPECULA 59000 manufactured by Welch Allyn.
[3773291]
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.
Patient Sequence No: 1, Text Type: D, B5
[11137456]
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 be related to potential impacts or loads on the shipping containers during transit or storage. Method: customer confirmed lower bill break. Result: vaginal speculum. Conclusion: actual device was returned - engineering confirmed failure mode by visual eval.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1316463-2013-00011 |
| MDR Report Key | 3415913 |
| Report Source | 06 |
| Date Received | 2013-09-04 |
| Date of Report | 2013-08-23 |
| Date of Event | 2013-08-23 |
| Date Mfgr Received | 2013-08-23 |
| Date Added to Maude | 2013-12-03 |
| 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, DIR |
| 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 |
| Product Code | HIB |
| Date Received | 2013-09-04 |
| Returned To Mfg | 2013-08-29 |
| Model Number | 59000 |
| Catalog Number | 59000 |
| 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 | 2013-09-04 |