FDA Adverse Event
Malfunction
Summary report: N
WOLF
MDR report key: 288891
·
Received August 4, 2000
Report
- Report Number
- MW1019469
- Event Type
- Malfunction
- Date Received
- August 4, 2000
- Date of Event
- July 28, 2000
- Report Date
- July 31, 2000
- Manufacturer
- RICHARD WOLF MEDICAL INSTRUMENTS
- Product Code
- KTF
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- AZ, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | WOLF | OSTIUM PUNCH | KTF | RICHARD WOLF MEDICAL INSTRUMENTS | 8211.661 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 38 YR | Other |