FDA Adverse Event
Malfunction
Summary report: N
LIGAMAX-5MM ENDO CLIP APPLIER
MDR report key: 1082923
·
Received July 25, 2008
Report
- Report Number
- 3005075853-2008-00687
- Event Type
- Malfunction
- Date Received
- July 25, 2008
- Date of Event
- July 14, 2008
- Report Date
- July 17, 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
- UK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A LAPAROSCOPIC GASTRIC PROCEDURE, THE CLIPS WOULD NOT REMAIN FIXED AND WERE NOT PROPERLY FORMED. THE DEVICE WAS ALSO FIRING 2 CLIPS AT ONCE. OPENED A COMPETITOR DEVICE TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. THE DEVICE WAS DISCARDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIGAMAX-5MM ENDO CLIP APPLIER | FZP | ETHICON ENDO-SURGERY, LLC | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |