FDA Adverse Event
Malfunction
Summary report: N
LIGAMAX-5MM ENDO CLIP APPLIER
MDR report key: 726418
·
Received June 13, 2006
Report
- Report Number
- 1527736-2006-02695
- Event Type
- Malfunction
- Date Received
- June 13, 2006
- Date of Event
- May 9, 2006
- Report Date
- May 22, 2006
- Manufacturer
- ETHICON ENDO SURGERY, INC.
- Product Code
- FZP
- PMA / PMN Number
- k050344
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
H4,6: INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. 510(K) NUMBER IS K050344.
Description of Event or Problem · 1
DURING A LAP GASTRIC BYPASSPROCEDURE THE JAWS WERE NOT LINED UP PROPERLY. A SECOND DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO OTHER INFO AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIGAMAX-5MM ENDO CLIP APPLIER | FZP | FZP | ETHICON ENDO SURGERY, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |