FDA Adverse Event
Malfunction
Summary report: N
LIGACLIP** ENDOSCOPIC CLIP APPLIER
MDR report key: 3000393
·
Received March 12, 2013
Report
- Report Number
- 3005075853-2013-01217
- Event Type
- Malfunction
- Date Received
- March 12, 2013
- Date of Event
- February 21, 2013
- Report Date
- March 1, 2013
- Manufacturer
- ETHICON ENDO-SURGERY, LLC.
- Product Code
- FZP
- PMA / PMN Number
- K864102
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
Additional Manufacturer Narrative · 1
(B)(4). THE ANALYSIS RESULTS FOUND THAT THE INSTRUMENT WAS RETURNED IN GOOD VISUAL CONDITION. IN AN ATTEMPT TO REPLICATE THE REPORTED INCIDENT, THE DEVICE WAS TESTED FOR FUNCTIONALITY. UPON TESTING THE DEVICE FOR FUNCTIONALITY THE DEVICE WAS CYCLED, FED, AND FORMED ONE CLIP AS INTENDED AND IT EJECTED TEN CLIPS. FINALLY, IT LOCKED OUT AS INTENDED. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.
Description of Event or Problem · 1
IT WAS REPORTED DURING A CHOLECYSTECTOMY PROCEDURE, THE CLIPS APPLIED BY THIS CLIP APPLIER FAILED TO CLOSE PROPERLY. THE CASE WAS CARRIED OUT AND FINISHED BY OPENING A NEW DEVICE FROM A DIFFERENT LOT. NO ADVERSE PATIENT CONSEQUENCES REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 104026 | LIGACLIP** ENDOSCOPIC CLIP APPLIER | CLIP, IMPLANTABLE | FZP | ETHICON ENDO-SURGERY, LLC. | NA | J4A67N |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |