FDA Adverse Event
Malfunction
Summary report: N
LIGACLIP** ENDOSCOPIC CLIP APPLIER
MDR report key: 2994403
·
Received March 8, 2013
Report
- Report Number
- 3005075853-2013-01130
- Event Type
- Malfunction
- Date Received
- March 8, 2013
- Report Date
- February 28, 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
- AZ, 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 SPITTING AND SCISSORING CLIPS. THIS OCCURRED AFTER THE FIRST FIRING OF THE DEVICE. A FEW CLIPS WENT INTO THE PATIENT BUT WERE RETRIEVED. THE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH NO PATIENT CONSEQUENCE. THE DEVICE WAS DISCARDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 100254 | LIGACLIP** ENDOSCOPIC CLIP APPLIER | CLIP, IMPLANTABLE | FZP | ETHICON ENDO-SURGERY, LLC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |