MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2001-04-20 for WOLF BOVIE CORD NOT AVAILABLE * manufactured by Richard Wolf, Inc..
[189249]
Non-disposable bovie cord broke during use (laparoscopic exam) cord sent out of room. Machine sent for inspection. No pt/shaft injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1021730 |
| MDR Report Key | 329392 |
| Date Received | 2001-04-20 |
| Date of Report | 2001-04-18 |
| Date of Event | 2001-04-17 |
| Date Added to Maude | 2001-05-02 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WOLF BOVIE CORD |
| Generic Name | BOVIE CORD |
| Product Code | FFZ |
| Date Received | 2001-04-20 |
| Model Number | NOT AVAILABLE |
| Catalog Number | * |
| Lot Number | * |
| ID Number | 3/00 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 318759 |
| Manufacturer | RICHARD WOLF, INC. |
| Manufacturer Address | 353 CORPORATE WOODS PKWY VERNON HILLS IL 60061 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2001-04-20 |