MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2014-06-03 for FORCEPS, TENACULUM 8370.26 manufactured by Richard Wolf Medical Instruments Corp.
[20654939]
Facility reported that during a case, after forceps were inserted into patient and opened, the instrument would not close. Doctor had to use a babcock in another incision in order to close device in question. When device was removed and tested, it worked. Doctor began to use device and once again had similar event occur. No patient injury reported. Minimal delay in closing device for removal.
Patient Sequence No: 1, Text Type: D, B5
[20873133]
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 will be completed as the actual device was returned to the rw (b)(4) facility on (b)(4) 2014. Device now being sent to endoplus for investigation. Richard wolf considers this matter open. When we receive information, we will provide fda with follow-up information.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1418479-2014-00028 |
| MDR Report Key | 3966741 |
| Report Source | 06 |
| Date Received | 2014-06-03 |
| Date of Report | 2014-05-07 |
| Date of Event | 2014-05-01 |
| Date Added to Maude | 2014-08-07 |
| 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 (RWMIC) |
| Manufacturer City | VERNON HILLS IL 60061 |
| Manufacturer Country | US |
| Manufacturer Postal | 60061 |
| Manufacturer Phone | 8479558016 |
| Manufacturer Street | 750 TOWER ROAD, SUITE A (ENDOPLUS) |
| 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 | 2014-06-03 |
| Returned To Mfg | 2014-05-12 |
| Model Number | 8370.26 |
| Catalog Number | 8370.26 |
| Lot Number | 51000189 |
| 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 60061 US 60061 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-06-03 |