FDA Adverse Event
Malfunction
Summary report: N
ETHICON CLIP APPLIERS
MDR report key: 204801
·
Received December 30, 1998
Report
- Report Number
- MW4002369
- Event Type
- Malfunction
- Date Received
- December 30, 1998
- Date of Event
- May 26, 1998
- Report Date
- September 16, 1998
- Manufacturer
- JOHNSON & JOHNSON
- Product Code
- GDO
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- PA, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
A 46 Y/O IN THE O.R. FOR LAPAROSCOPIC CHOLECYSTECTOMY. ENDOSCOPIC CLIP APPLIERS FAILED TO CLIP PROPERLY. NO ADVERSE OUTCOME TO PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ETHICON CLIP APPLIERS | * | GDO | JOHNSON & JOHNSON | ER 420 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 46 YR | Other |