FDA Adverse Event
Malfunction
Summary report: N
LIGAMAX-5MM ENDO CLIP APPLIER
MDR report key: 1915166
·
Received December 6, 2010
Report
- Report Number
- 3005075853-2010-06878
- Event Type
- Malfunction
- Date Received
- December 6, 2010
- Date of Event
- October 21, 2010
- Report Date
- November 12, 2010
- Manufacturer
- ETHICON ENDO-SURGERY, LLC.
- Product Code
- FZP
- PMA / PMN Number
- K050344
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). DEVICE NOT RETURNED THE COMPLAINT COULD NOT BE CONFIRMED BECAUSE NO DEVICE WAS RETURNED FOR ANALYSIS. THE DEVICE HISTORY RECORDS WERE REVIEWED AND THE MANUFACTURING CRITERIA WAS MET PRIOR TO THE RELEASE OF THE BATCHES INCLUDED IN THIS LOT.
Additional Manufacturer Narrative · 1
(B)(4): INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.(B)(4)
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE DEVICE LOCKED ON THE BILE DUCT THEN IT WAS REMOVED BY RIPPING IT OFF FROM TISSUE. THERE WAS TISSUE DAMAGE THAT WAS REPAIRED BY CLIPPING AROUND THE TEAR. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE CONSEQUENCES REPORTED.
Description of Event or Problem · 1
PT WAS REVISED TO ADDRESS ONGOING INFECTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIGAMAX-5MM ENDO CLIP APPLIER | CLIP, IMPLANTABLE | FZP | ETHICON ENDO-SURGERY, LLC. | G4TT36 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |