FDA Adverse Event
Malfunction
Summary report: N
FZP CLIP, IMPLANTABLE
MDR report key: 1447172
·
Received June 2, 2009
Report
- Report Number
- 3005075853-2009-03239
- Event Type
- Malfunction
- Date Received
- June 2, 2009
- Date of Event
- May 8, 2009
- Report Date
- May 19, 2009
- Manufacturer
- ETHICON ENDO-SURGERY, LLC.
- Product Code
- FZP
- PMA / PMN Number
- K050344
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NM, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B) (4). (B) (4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A LAP CHOLECYSTECTOMY PROCEDURE, THE CLIP APPLIER JAWS LOCKED IN THE TROCAR. THERE WERE NO PT CONSEQUENCES. CASE COMPLETED WITH ANOTHER DEVICE OF THE SAME PRODUCT CODE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FZP CLIP, IMPLANTABLE | FZP | ETHICON ENDO-SURGERY, LLC. | NA | F4N43U |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |