FDA Adverse Event
Malfunction
Summary report: N
ENDOPATH ELECTRO SURGERY PROBE PLUS II
MDR report key: 109529
·
Received July 8, 1997
Report
- Report Number
- 109529
- Event Type
- Malfunction
- Date Received
- July 8, 1997
- Date of Event
- June 15, 1997
- Report Date
- June 24, 1997
- Manufacturer
- ETHICON, INC.
- Product Code
- FEH
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
RIGHT ANGLE TIP OF PROBE BECAME DISLODGED. SURGEON UNABLE TO FIND IN WOUND.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDOPATH ELECTRO SURGERY PROBE PLUS II | MONOPOLAR CAUTERY SUCTION & IRRIGATION SHAFT | FEH | ETHICON, INC. | EPS03 | J45971 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Other |