FDA Adverse Event
Malfunction
Summary report: N
LIGAMAX-5MM ENDO CLIP APPLIER
MDR report key: 1080032
·
Received July 17, 2008
Report
- Report Number
- 3005075853-2008-00556
- Event Type
- Malfunction
- Date Received
- July 17, 2008
- Date of Event
- June 20, 2008
- Report Date
- June 23, 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
- UT, 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 AN UNKNOWN PROCEDURE, THE DEVICE FIRED RANDOM CLIPS THAT DID NOT CLOSE PROPERLY. UNKNOWN HOW CASE WAS COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES 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 | E4KK2U |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |