MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,06,08 report with the FDA on 2014-05-16 for FORCEPS, TENACULUM 8370.26 manufactured by Richard Wolf Medical Instruments Corp..
[15122737]
Device broke, no injury or delay in procedure was reported. Two devices involved, they consist of the following: 1) tenaculum (8370. 26), report: 1418479-2014-00020; 2) tenaculum (8370. 26), report: 1418479-2014-00021.
Patient Sequence No: 1, Text Type: D, B5
[15400181]
Handle is manufactured by richard wolf. It is then sent to endoplus where they manufacture and attach the insulated sheath and forceps. Completed device is then returned to richard wolf for distribution. An investigation was completed as the actual device was returned to the rwmic facility on (b)(4) 2013. Device was then sent to (b)(4) for additional investigation. Investigation revealed incorrect handle had been assembled on forceps. Manufacture date: nov 2011. 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 | 1418479-2014-00020 |
| MDR Report Key | 3898958 |
| Report Source | 00,06,08 |
| Date Received | 2014-05-16 |
| Date of Report | 2012-01-13 |
| Date of Event | 2012-01-01 |
| Device Manufacturer Date | 2011-11-01 |
| Date Added to Maude | 2014-07-10 |
| 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 PKWY. |
| Manufacturer City | VERNON HILLS IL 60061 |
| Manufacturer Country | US |
| Manufacturer Postal | 60061 |
| Manufacturer Phone | 8479558016 |
| Manufacturer Street | 750 TOWER RD STE A |
| Manufacturer City | MUNDELEIN IL 60060 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60060 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FORCEPS, TENACULUM |
| Generic Name | FORCEPS |
| Product Code | HCZ |
| Date Received | 2014-05-16 |
| Returned To Mfg | 2012-01-26 |
| Model Number | 8370.26 |
| Catalog Number | 8370.26 |
| Lot Number | 1N11 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
| Manufacturer Address | VERNON HILLS IL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-05-16 |