MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,05,06 report with the FDA on 2010-04-07 for WAVE SIDE GRASPER FORCEPS 8383.2937 manufactured by Richard Wolf Medical Instruments.
[1582248]
It was reported that while using the grasper during a laparoscopic sigmoid resection, the jaw broke off inside the patient. The piece was retrieved and accounted for by the surgeon and the or staff. The jaw piece was discarded. There was no patient injury.
Patient Sequence No: 1, Text Type: D, B5
[8539242]
Jaw broken. Evaluation summary: visual inspection of the forceps with broken jaw showed no corrosion at the point of breakage. The forceps is approximately 6 years old. The insulation is in good condition. Our repair records show that this facility purchased a more than one of these forceps of this lot number 1u03 in 2004. We consider this an isolated occurrence since no other complaints of this type are in the system. Cause of event: normal wear and tear for this period of time in use.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1418479-2010-00005 |
| MDR Report Key | 1655135 |
| Report Source | 00,05,06 |
| Date Received | 2010-04-07 |
| Date of Report | 2010-04-07 |
| Date of Event | 2010-02-22 |
| Date Mfgr Received | 2010-03-11 |
| Device Manufacturer Date | 2003-08-01 |
| Date Added to Maude | 2011-02-18 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | ELEANOR HALL |
| Manufacturer Street | 353 CORPORATE WOODS PKWY. |
| Manufacturer City | VERNON HILLS IL 60061 |
| Manufacturer Country | US |
| Manufacturer Postal | 60061 |
| Manufacturer Phone | 8479558016 |
| Manufacturer G1 | ENDOPLUS |
| Manufacturer Street | 431 LEXINGTON DRIVE |
| Manufacturer City | BUFFALO GROVE IL 60089 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60089 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WAVE SIDE GRASPER FORCEPS |
| Generic Name | WAVE SIDE GRASPER FORCEPS |
| Product Code | BWB |
| Date Received | 2010-04-07 |
| Returned To Mfg | 2010-03-31 |
| Model Number | 8383.2937 |
| Catalog Number | 8383.2937 |
| Lot Number | 1U03 |
| 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 |
| Manufacturer Address | VERNON HILLS IL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-04-07 |