MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2013-09-19 for INSERT, BIPOLAR FORCEPS 8393.705 manufactured by Richard Wolf Medical Instrumetn Corp (rwmic).
[15157725]
Richard wolf medical instrument corp (rwmic) was notified by facility that during a tubal ligation, instrument system came apart. Additional time was needed in order to complete procedure; therefore, increasing risk to pt. Four devices combine into one system, they consist of the following: handle (8393. 974), report 1418479-2013-00020; outer tube (8393. 924), report 1418479-2013-00021; sleeve (8393. 923), report 1418479-2013-00022; forcep insert (8393. 705), report 1418479-2013-00023.
Patient Sequence No: 1, Text Type: D, B5
[15465354]
An investigation was completed as the actual device was returned to the richard wolf facility on (b)(4) 2013. Complete system put together and no issues were found that would make the system fall apart. Hy-pot tester used to test insert, device had an electrical short. Device is over 3 years old. Rwmic has no similar complaints on file. Labeling was reviewed and found to be adequate. Intended use, indication and field of use, preparation and cautions. Richard wolf considers this matter closed. However, in the event we receive additional information, we will provide fda with follow-up information.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1418479-2013-00023 |
| MDR Report Key | 3365220 |
| Report Source | 06,07 |
| Date Received | 2013-09-19 |
| Date of Report | 2013-08-20 |
| Date Mfgr Received | 2013-08-21 |
| Device Manufacturer Date | 2010-05-01 |
| Date Added to Maude | 2013-09-26 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | DAWN CLARK |
| Manufacturer Street | 353 CORPORATE WOODS PARKWAY |
| Manufacturer City | VERNON HILLS IL 60061 |
| Manufacturer Country | US |
| Manufacturer Postal | 60061 |
| Manufacturer Phone | 8479558016 |
| Manufacturer G1 | RICHARD WOLF MEDICAL INSTRUMENTS CORP |
| Manufacturer Street | 353 CORPORATE WOODS PKWY. |
| Manufacturer City | VERNON HILLS IL 60061 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60061 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INSERT, BIPOLAR FORCEPS |
| Generic Name | INSERT |
| Product Code | HIN |
| Date Received | 2013-09-19 |
| Model Number | 8393.705 |
| Catalog Number | 8393.705 |
| Lot Number | 249Y10 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RICHARD WOLF MEDICAL INSTRUMETN CORP (RWMIC) |
| Manufacturer Address | VERNON HILLS IL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-09-19 |