FDA Adverse Event
Malfunction
Summary report: N
*
MDR report key: 293946
·
Received August 30, 2000
Report
- Report Number
- 1527736-2000-04094
- Event Type
- Malfunction
- Date Received
- August 30, 2000
- Date of Event
- June 16, 2000
- Manufacturer
- ETHICON ENDO-SURGERY, INC.
- Product Code
- GDO
- Removal / Correction Number
- NA
- Report Source
- Manufacturer report
Narratives
Description of Event or Problem · 1
IT WAS REPORTED ON AN EXTERNAL MEDWATCH THAT THE ETHICON LIGACLIP WAS MALFUNCTIONING. IT WAS NOT CLIPPING AT ALL TIMES, STAPLES WERE FALLING OUT, AND THE HANDLE WOULD NOT CLOSE. THERE WAS A PROLONGED PROCEDURE TIME. 08/23/2000 THE DEVICE IS AN ER320.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | * | * | GDO | ETHICON ENDO-SURGERY, INC. | NA | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |