FDA Adverse Event
Malfunction
Summary report: N
LIGACLIP MCA
MDR report key: 2924635
·
Received January 16, 2013
Report
- Report Number
- 2924635
- Event Type
- Malfunction
- Date Received
- January 16, 2013
- Date of Event
- December 28, 2012
- Report Date
- January 16, 2013
- Manufacturer
- ETHICON ENDO-SURGERY, INC
- Product Code
- FZP
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- CO, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
THE SMALL CLIP GUN WORKED THE FIRST TIME IT WAS USED THEN FAILED TO LOAD A CLIP FAR ENOUGH TO BE USED AGAIN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 24150 | LIGACLIP MCA | CLIP, IMPLANTABLE | FZP | ETHICON ENDO-SURGERY, INC | MCS20 | J4CM1J |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR |