FDA Adverse Event
Injury
Summary report: N
ETHICON 10MM LIGACLIP
MDR report key: 3040026
·
Received April 2, 2013
Report
- Report Number
- MW5029611
- Event Type
- Injury
- Date Received
- April 2, 2013
- Date of Event
- February 26, 2013
- Report Date
- March 21, 2013
- Manufacturer
- ETHICON - ENDO SURGERY INC.
- Product Code
- FZP
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- MD, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
A 5MM LAPAROSCOPIC CLIP APPLIER WAS BEING USED FOR A LAPAROSCOPIC CHOLECYSTECTOMY. CLIP APPLIER FIRED; CLIP WAS TOO LOOSE TO SEAL VESSEL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 134906 | ETHICON 10MM LIGACLIP | LIGACLIP | FZP | ETHICON - ENDO SURGERY INC. | J4CV48 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 46 YR | Required Intervention |