FDA Adverse Event
Malfunction
Summary report: N
LIGAMAX-5MM ENDO CLIP APPLIER
MDR report key: 1190904
·
Received October 9, 2008
Report
- Report Number
- 1527736-2008-03520
- Event Type
- Malfunction
- Date Received
- October 9, 2008
- Date of Event
- May 19, 2008
- Report Date
- May 19, 2008
- Manufacturer
- ETHICON ENDO SURGERY, INC. (CINCINNATI)
- Product Code
- FZP
- PMA / PMN Number
- K050344
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- 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 A LAP CHOLECYSTECTOMY PROCEDURE, ONE CLIP HAD CROSSED LEGS AND THE OTHER CLIP WAS NOT CLOSED AT THE DISTAL END. A SECOND DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE PT CONSEQUENCE WAS REPORTED.
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 | E4KH8A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |