FDA Adverse Event
Summary report: N
LIGACLIP
MDR report key: 3232381
·
Received July 8, 2013
Report
- Report Number
- 3232381
- Date Received
- July 8, 2013
- Report Date
- July 8, 2013
- Manufacturer
- ETHICON ENDO-SURGERY, INC.
- Product Code
- FZP
- Report Source
- User Facility report
- Reporter Location
- CA, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
LIGACLIPS FIRED BY SURGEON: CLIPS NOT CLOSING ACROSS VESSEL COMPLETELY TO OCCLUDE. FIRED MULTIPLE CLIPS AND NONE FIRED CLOSED CORRECTLY.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?NA.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 310915 | LIGACLIP | CLIP, IMPLANTABLE | FZP | ETHICON ENDO-SURGERY, INC. | * | K4CG21 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 49 YR |