FDA Adverse Event
Injury
Summary report: N
10 MM ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER
MDR report key: 3020801
·
Received March 20, 2013
Report
- Report Number
- MW5029461
- Event Type
- Injury
- Date Received
- March 20, 2013
- Report Date
- March 20, 2013
- Manufacturer
- ETHICON
- Product Code
- FZP
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
PT ADMITTED WITH ABD PAIN. THE PT UNDERWENT A LAP CHOLE WITH IOC ON (B)(6) 2013. THE SURGEON REPORTED THAT WHEN HE FIRED THE LAP CLIP APPLIER GUN IT FAILED, SO HE GOT ANOTHER ONE AND IT WORKED FOR THE FIRST 2 CLIPS AND FAILED ON THE FOLLOWING 4 CLIPS. WE HAVE ORIGINAL CLIPS THAT FAILED. THIS LOT # IS THE 2ND LAP CLIP APPLIER THAT FAILED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 115753 | 10 MM ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER | LIGA CLIP 10 ML DISPOSABLE W/20 MED-LG TITANIUM CLIPS | FZP | ETHICON | REF ER320 | K4C58G |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization |