FDA Adverse Event
Malfunction
Summary report: N
ETHICON ENDO-SURGERY, INC.
MDR report key: 853198
·
Received May 18, 2007
Report
- Report Number
- MW5001888
- Event Type
- Malfunction
- Date Received
- May 18, 2007
- Manufacturer
- ETHICON ENDO-SURGERY, INC.
- Product Code
- GCJ
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- CA, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
EMERGENCY RELEASE WOULD NOT RELEASE JAWS CAUSING SURGEON TO RESECT MORE BOWEL AND TURNING A LAPAROSCOPIC PROCEDURE INTO A OPEN PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ETHICON ENDO-SURGERY, INC. | ENDOSCOPIC LINEAR CUTTER-STRAIGHT | GCJ | ETHICON ENDO-SURGERY, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR | Other |