MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2015-02-11 for KLEENSPEC 590 SEERIES DISP. VIGINAL SPECULA 59000 manufactured by Welch Allyn, Inc..
[16556408]
Customer stated that lower blade of speculum broke in use during a pt vaginal examination. The physician was able to remove the speculum without causing any harm or injury to the pt.
Patient Sequence No: 1, Text Type: D, B5
[16813145]
Welch allyn is reporting this in an abundance of caution. The actual speculum involved in the incident was returned and evaluated by welch allyn. The speculum was evaluated by engineering, and the failure mode matches the one that was 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. Conclusion code: eval conclusion (refer to the eval above).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1316463-2015-00008 |
| MDR Report Key | 4544254 |
| Report Source | 04 |
| Date Received | 2015-02-11 |
| Date of Report | 2015-01-21 |
| Date of Event | 2015-01-01 |
| Date Mfgr Received | 2015-01-21 |
| Device Manufacturer Date | 2012-04-01 |
| Date Added to Maude | 2015-03-24 |
| 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 BRAMBRI, RA 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 SEERIES DISP. VIGINAL SPECULA |
| Generic Name | VAGINAL SPECULA |
| Product Code | HIB |
| Date Received | 2015-02-11 |
| Returned To Mfg | 2015-02-02 |
| Model Number | 59000 |
| Catalog Number | 59000 |
| Lot Number | 175242 |
| 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, INC. |
| Manufacturer Address | 4341 STATE ST. RD. SKANEATELES FALLS NY 13153 US 13153 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-02-11 |