MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-08-04 for WOLF 8211.661 manufactured by Richard Wolf Medical Instruments.
[187758]
Ostium punch broke around hinge area of blade while being used on soft tissues. A very small piece was unable to be retrieved from pt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1019469 |
| MDR Report Key | 288891 |
| Date Received | 2000-08-04 |
| Date of Report | 2000-07-31 |
| Date of Event | 2000-07-28 |
| Date Added to Maude | 2000-08-10 |
| 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 |
| 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 |
| Generic Name | OSTIUM PUNCH |
| Product Code | KTF |
| Date Received | 2000-08-04 |
| Model Number | 8211.661 |
| Catalog Number | 8211.661 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 279568 |
| Manufacturer | RICHARD WOLF MEDICAL INSTRUMENTS |
| Manufacturer Address | 353 CORPORATE WOODS PKWY VERNON HILLS IL 60061 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2000-08-04 |