FDA Adverse Event
Injury
Summary report: N
MITEK
MDR report key: 158158
·
Received March 20, 1998
Report
- Report Number
- 158158
- Event Type
- Injury
- Date Received
- March 20, 1998
- Date of Event
- March 12, 1998
- Report Date
- March 18, 1998
- Manufacturer
- MITEK SURGICAL PRODUCTS, INC.
- Product Code
- GEI
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- CA, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
TIP OF CERAMIC VAPR PROBE BROKE OFF IN KNEE BUT WAS RETRIEVED BY THE SURGEON. NO HARM WAS CAUSED TO THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MITEK | VAPR ANGLED SIDE EFFECT ELECTRODE | GEI | MITEK SURGICAL PRODUCTS, INC. | * | 9712806 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 41 YR | Required Intervention |