FDA Adverse Event
Malfunction
Summary report: N
VAPR S90ELECTRODE
MDR report key: 1640008
·
Received March 22, 2010
Report
- Report Number
- 1640008
- Event Type
- Malfunction
- Date Received
- March 22, 2010
- Date of Event
- January 13, 2010
- Report Date
- March 22, 2010
- Manufacturer
- DEPUY MITEK INC
- Product Code
- GEI
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- CT, US
Narratives
Description of Event or Problem · 1
DURING KNEE ARTHROSCOPY, THE PHYSICIAN NOTED THE ELECTRODE TIP WAS CRACKED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VAPR S90ELECTRODE | SUCTION ELECTRODE | GEI | DEPUY MITEK INC | * | M080065 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR |