FDA Adverse Event
Malfunction
Summary report: N
LIGAMAX-5MM ENDO CLIP APPLIER
MDR report key: 3002718
·
Received March 13, 2013
Report
- Report Number
- 3005075853-2013-01244
- Event Type
- Malfunction
- Date Received
- March 13, 2013
- Report Date
- March 4, 2013
- 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
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE CLIPS WERE FALLING OFF THE TISSUE AND SCISSORING. ONE OF THE SCISSORED CLIPS CUT THE VESSEL. IT IS UNKNOWN WHAT OCCURRED AFTER THE CLIP CUT THE VESSEL OR HOW THE CLIPS WERE RETRIEVED. UNKNOWN HOW THE CASE WAS COMPLETED. THERE WAS NO PATIENT CONSEQUENCE. THE DEVICE WAS DISCARDED. NO FURTHER INFORMATION AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 105533 | LIGAMAX-5MM ENDO CLIP APPLIER | CLIP, IMPLANTABLE | FZP | ETHICON ENDO-SURGERY, LLC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |