MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2015-01-13 for KLEENSPEC 590 SERIES DISP. VAGINAL SPECULA 59001 manufactured by Welch Allyn, Inc..
[5169030]
A customer informed welch allyn of a vaginal speculum break in a patient. The doctor was using a medium speculum in a patient. When the speculum opened, the locking mechanism failed and the patient felt immediate pain. The doctor noticed that the bill of the speculum cracked down the middle and caused a 2 cm laceration down the right side of the patient's vaginal wall. The patient was already being treated with an antibiotic for an unrelated issue, so doctor extended the prescription by 5 days as a precaution. The patient came back in one week for a follow-up and the laceration was healing with no signs or symptoms of infection. No further treatment was provided to the patient. In subsequent follow-up, the customer identified that it was the lower bill of the speculum that broke.
Patient Sequence No: 1, Text Type: D, B5
[12875639]
Welch allyn is reporting this in an abundance of caution. The customer did not return the device that broke in use to welch allyn as the device was previously discarded. The customer did return a damaged device to welch allyn, discovered before use, with the same break pattern as the device involved in the event. The device was reviewed by welch allyn engineering and the failure mode matched 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 | 1316463-2015-00001 |
| MDR Report Key | 4428357 |
| Report Source | 04 |
| Date Received | 2015-01-13 |
| Date of Report | 2014-12-18 |
| Date of Event | 2014-12-18 |
| Date Mfgr Received | 2014-12-18 |
| Date Added to Maude | 2015-01-30 |
| 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 | 2015-01-13 |
| Model Number | 59001 |
| Catalog Number | 59001 |
| 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 | 2015-01-13 |