FDA Adverse Event
Malfunction
Summary report: N
LIGAMAX-5MM ENDO CLIP APPLIER
MDR report key: 1316619
·
Received February 20, 2009
Report
- Report Number
- 1527736-2008-01773
- Event Type
- Malfunction
- Date Received
- February 20, 2009
- Date of Event
- February 28, 2008
- Report Date
- February 28, 2008
- Manufacturer
- ETHICON ENDO-SURGERY, INC.
- Product Code
- FZP
- PMA / PMN Number
- K050344
- Removal / Correction Number
- NA
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DATE SENT: 03/24/2008. INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A LAP CHOLE PROCEDURE, THE DEVICE FIRED INCORRECTLY FORMED CLIPS. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PT CONSEQUENCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIGAMAX-5MM ENDO CLIP APPLIER | FZP | FZP | ETHICON ENDO-SURGERY, INC. | NA | D4JX1Y |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |