FDA Adverse Event
Malfunction
Summary report: N
LIGACLIP MCA
MDR report key: 3001489
·
Received February 25, 2013
Report
- Report Number
- 3001489
- Event Type
- Malfunction
- Date Received
- February 25, 2013
- Date of Event
- January 31, 2013
- Report Date
- February 5, 2013
- Manufacturer
- ETHICON ENDO-SURGERY, INC.
- Product Code
- GDO
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- MO, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
THE FIRST CLIP JAMMED WHILE TRYING TO DISCHARGE FROM THE DEVICE. IT WAS STUCK ON THE VESSEL, BUT AFTER MUCH MANIPULATION, IT WAS ABLE TO BE FULLY DISCHARGED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 79191 | LIGACLIP MCA | APPLIER, SURGICAL, CLIP | GDO | ETHICON ENDO-SURGERY, INC. | MSM20 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR |