FDA Adverse Event
Malfunction
Summary report: N
LIGAMAX- 5MM ENDO CLIP APPLIER
MDR report key: 1083040
·
Received July 23, 2008
Report
- Report Number
- 3005075853-2008-00641
- Event Type
- Malfunction
- Date Received
- July 23, 2008
- Date of Event
- June 25, 2008
- Report Date
- June 26, 2008
- Manufacturer
- ETHICON ENDO-SURGERY, LLC.
- 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
INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A LAP CHOLECYSTECTOMY, THE JAWS WOULD NOT OPEN. THE DEVICE WAS NOT ON TISSUE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO CONSEQUENCE TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIGAMAX- 5MM ENDO CLIP APPLIER | FZP | ETHICON ENDO-SURGERY, LLC. | NA | E4L43U |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |