FDA Adverse Event
Malfunction
Summary report: N
LIGACLIP** ENDOSCOPIC CLIP APPLIER
MDR report key: 3030162
·
Received April 2, 2013
Report
- Report Number
- 3005075853-2013-01537
- Event Type
- Malfunction
- Date Received
- April 2, 2013
- Date of Event
- March 7, 2013
- Report Date
- March 7, 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
- CT, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). DEVICE WAS NOT RETURNED FOR EVALUATION.
Description of Event or Problem · 1
ITWAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE LEGS OF THE CLIP ARE CROSSING ON THE INITIAL FIRE. A NEW DEVICE WAS OPENED AND THE FIRST FIRING OF THAT DEVICE THE LEGS OF THE CLIPS WERE CROSSED. A THIRD DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT IMPACT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 133501 | LIGACLIP** ENDOSCOPIC CLIP APPLIER | CLIP, IMPLANTABLE | FZP | ETHICON ENDO-SURGERY, LLC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |