FDA Adverse Event
Malfunction
Summary report: N
ETHICON ENDO-SURGERY, INC.
MDR report key: 227590
·
Received June 14, 1999
Report
- Report Number
- MW1016532
- Event Type
- Malfunction
- Date Received
- June 14, 1999
- Date of Event
- December 19, 1998
- Report Date
- May 24, 1999
- Manufacturer
- ETHICON ENDO-SURGERY, INC.
- Product Code
- GAG
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- CA, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
1 PROXIMATE RELOADABLE LINER STAPLER DID NOT FIRE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ETHICON ENDO-SURGERY, INC. | 1 PROXIMATE RELOADABLE LINEAR STAPLER | GAG | ETHICON ENDO-SURGERY, INC. | 30MM | CE 0123 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 84 YR |