MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2009-11-20 for ETHMOID FORCEPS STRAIGHT 8211.09 manufactured by Richard Wolf Gmbh.
[1454454]
During a sinus procedure (landmarx image guided fess), the jaw broke. The jaw piece and forceps were collected for return to manufacturer. There was no pt consequence.
Patient Sequence No: 1, Text Type: D, B5
[8501782]
Evaluation summary: 8211. 09 - ethmoid forceps straight - lot #: unk. The ethmoid forceps were inspected and broken jaw was confirmed. The broken jaw was not included in the returned package. We do not know if it was discarded within our facility, or at the user facility. The ethmoid forceps is, from appearance, 10 plus years old. The ethmoid forceps are designed to grasp, not cut tissue. The tissue is removed by grasping and pulling it gently away from the muscosa or bone. Cause: use and handling with excess force applied to the jaw during use.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1418479-2009-00017 |
| MDR Report Key | 1547910 |
| Report Source | 06 |
| Date Received | 2009-11-20 |
| Date of Report | 2009-11-20 |
| Date of Event | 2009-10-07 |
| Date Facility Aware | 2009-10-30 |
| Report Date | 2009-11-20 |
| Date Reported to FDA | 2009-11-20 |
| Date Mfgr Received | 2009-10-30 |
| Date Added to Maude | 2010-08-31 |
| 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 | 3 |
| Event Location | 3 |
| 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 | RICHARD WOLF GMBH |
| Manufacturer Street | PFORZHEIMER STRABE 32 |
| Manufacturer City | KNITTLENGEN 75438 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 75438 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ETHMOID FORCEPS STRAIGHT |
| Generic Name | ETHMOID FORCEPS STRAIGHT |
| Product Code | JXX |
| Date Received | 2009-11-20 |
| Returned To Mfg | 2009-11-06 |
| Model Number | 8211.09 |
| Catalog Number | 8211.09 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 10 YR |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RICHARD WOLF GMBH |
| Manufacturer Address | KNITTLENGEN GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-11-20 |