FDA Adverse Event
Malfunction
Summary report: N
FZP CLIP, IMPLANTABLE
MDR report key: 1432545
·
Received May 5, 2009
Report
- Report Number
- 3005075853-2009-02696
- Event Type
- Malfunction
- Date Received
- May 5, 2009
- Date of Event
- April 10, 2009
- Report Date
- April 14, 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). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A CHOLECYSTECTOMY PROCEDURE, THE JAW WOULD NOT OPEN AFTER THE FIRING. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FZP CLIP, IMPLANTABLE | FZP | ETHICON ENDO-SURGERY, LLC | NA | F4MY4A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |