MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-04-05 for WINER GRASPING FORCEPS, IN-LINE, RATCHET, 5MM, 33CM * 600-123 manufactured by *.
[597568]
It has been reported that while the physician was performing lap g. B. While working with and manipulating the assisted duct, the instrument jaw broke inside the pt. The broken piece was retrieved, and is available for return and eval.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2430952-2007-00011 |
| MDR Report Key | 839190 |
| Date Received | 2007-04-05 |
| Date of Report | 2007-04-05 |
| Date Facility Aware | 2007-03-06 |
| Report Date | 2007-04-05 |
| Date Added to Maude | 2007-04-20 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| 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 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WINER GRASPING FORCEPS, IN-LINE, RATCHET, 5MM, 33CM |
| Generic Name | ENDOSCOPIC INSTRUMENT |
| Product Code | EMH |
| Date Received | 2007-04-05 |
| Model Number | * |
| Catalog Number | 600-123 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 826465 |
| Manufacturer | * |
| Manufacturer Address | * * * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-04-05 |