FDA Adverse Event
Injury
Summary report: N
ETHICON
MDR report key: 43359
·
Received September 16, 1996
Report
- Report Number
- 43359
- Event Type
- Injury
- Date Received
- September 16, 1996
- Date of Event
- September 5, 1996
- Report Date
- September 10, 1996
- Manufacturer
- ETHICON
- Product Code
- DSS
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- KS, US
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
LAPAROSCOPIC CHOLECYSTECTOMY CLIP APPLIED TO ARTERY. CLIP CAME OFF THE ARTERY. THE CASE WAS CONVERTED TO AN OPEN PROCEDURE AND THE ARTERY LIGATED. THIS EXTENDED THE RECOVERY TIME AND HOSPITALIZATION OF THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ETHICON Implant | LMC-20 CLIP APPLIER | DSS | ETHICON | ERCAM/L | UNK (TRACE CART) |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 39 YR | Required Intervention |