FDA Adverse Event
Malfunction
Summary report: N
LIGAMAX-5MM ENDO CLIP APPLIER
MDR report key: 1318734
·
Received February 23, 2009
Report
- Report Number
- 1527736-2008-01232
- Event Type
- Malfunction
- Date Received
- February 23, 2009
- Date of Event
- February 6, 2008
- Report Date
- February 7, 2008
- Manufacturer
- ETHICON ENDO SURGERY, INC. (CINCINNATI)
- Product Code
- FZP
- PMA / PMN Number
- K050344
- Removal / Correction Number
- NA
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING CHOLECYSTECTOMY, THE CLIP MALFORMED. ALSO THE JAW DID NOT OPEN WHEN IT FED TO THE JAW. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO CONSEQUENCES TO THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIGAMAX-5MM ENDO CLIP APPLIER | NONE | FZP | ETHICON ENDO SURGERY, INC. (CINCINNATI) | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |