FDA Adverse Event
Malfunction
Summary report: N
ENDOSCOPIC MULTIPLE CLIP APPLIER
MDR report key: 957381
·
Received April 24, 2007
Report
- Report Number
- 1527736-2007-02956
- Event Type
- Malfunction
- Date Received
- April 24, 2007
- Date of Event
- March 22, 2007
- Report Date
- April 2, 2007
- Manufacturer
- ETHICON ENDO-SURGERY, INC.
- Product Code
- FZP
- PMA / PMN Number
- K864102
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
NFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A LAP CHOLECYSTECTOMY, THE STAPLES WERE NOT APPLIED PROPERLY AND FELL OUT FROM THE DEVICE. THE JAWS OF THE DEVICE REMAINED OPEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. NO PT CONSEQUENCES WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDOSCOPIC MULTIPLE CLIP APPLIER | FZP | FZP | ETHICON ENDO-SURGERY, INC. | NA | C4FV2Z |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |