FDA Adverse Event
Injury
Summary report: N
ETHICON
MDR report key: 2771597
·
Received September 27, 2012
Report
- Report Number
- MW5027096
- Event Type
- Injury
- Date Received
- September 27, 2012
- Date of Event
- September 26, 2012
- Report Date
- September 27, 2012
- Manufacturer
- ETHICON ENDO-SURGERY INC.
- Product Code
- FZP
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- MI, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
WHILE ATTEMPTING TO CLIP THE CYSTIC ARTERY, THE TWO ARMS OF THE CLIP CROSSED, CAUSING THE ARTERY TO RUPTURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ETHICON | LIGACLIP 10-M/L | FZP | ETHICON ENDO-SURGERY INC. | ER320 | J4C91W OR J4C42C |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Required Intervention |