FDA Adverse Event
Malfunction
Summary report: N
FZP CLIP, IMPLANTABLE
MDR report key: 1432008
·
Received May 4, 2009
Report
- Report Number
- 3005075853-2009-02674
- Event Type
- Malfunction
- Date Received
- May 4, 2009
- Date of Event
- April 10, 2009
- Report Date
- April 13, 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
DATE SENT: 5/4/2009. INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A LAPAROSCOPIC ASSISTED DISTAL GASTRECTOMY PROCEDURE, THE JAW COULD NOT BE OPENED AFTER THE FIRST FIRING. WHEN THE JAW WAS TOUCHED WITH FORCEPS SEVERAL TIMES, IT EVENTUALLY OPENED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NOT 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 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |