FDA Adverse Event
Malfunction
Summary report: N
LIGACLIP** ENDOSCOPIC CLIP APPLIER
MDR report key: 3103272
·
Received May 9, 2013
Report
- Report Number
- 3005075853-2013-02214
- Event Type
- Malfunction
- Date Received
- May 9, 2013
- Date of Event
- April 15, 2013
- Report Date
- April 15, 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
- NY, 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 SURGEON HAS HAD PROBLEMS RECENTLY WITH MALFORMED CLIPS. NO OTHER INFORMATION IS AVAILABLE AT THIS TIME. THERE WERE NO PATIENT CONSEQUENCES. UNKNOWN HOW CASE WAS COMPLETED. ONE DEVICE WAS DISCARDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 202879 | LIGACLIP** ENDOSCOPIC CLIP APPLIER | CLIP, IMPLANTABLE | FZP | ETHICON ENDO-SURGERY, LLC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |