FDA Adverse Event
Malfunction
Summary report: N
FZP CLIP, IMPLANTABLE
MDR report key: 1395856
·
Received April 1, 2009
Report
- Report Number
- 3005075853-2009-01954
- Event Type
- Malfunction
- Date Received
- April 1, 2009
- Date of Event
- March 6, 2009
- Report Date
- March 10, 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
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B) (4). (B) (4). INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A CHOLECYSTECTOMY PROCEDURE, THE JAW COULD NOT BE OPENED AFTER THE TRIGGER WAS GRASPED COMPLETELY. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FZP CLIP, IMPLANTABLE | FZP | ETHICON ENDO-SURGERY, LLC | NA | E4MM2F |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |