FDA Adverse Event
Malfunction
Summary report: N
ARTHROCARE TRISTAR 50
MDR report key: 752881
·
Received June 17, 2005
Report
- Report Number
- MW1035794
- Event Type
- Malfunction
- Date Received
- June 17, 2005
- Date of Event
- June 17, 2005
- Report Date
- June 17, 2005
- Manufacturer
- ARTHROCARE
- Product Code
- HRX
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- FL, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
TIP OF ARTHROSCOPIC WAND BROKE OFF IN KNEE DURING ARTHROSCOPY. EXPIRATION DATE ON PACKAGE 10/2007.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ARTHROCARE TRISTAR 50 | ARTHROSCOPY WAND | HRX | ARTHROCARE | ASC4630-01 | 5C33541-2 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR |