FDA Adverse Event
Malfunction
Summary report: N
FZP CLIP, IMPLANTABLE
MDR report key: 1432645
·
Received May 8, 2009
Report
- Report Number
- 3005075853-2009-02769
- Event Type
- Malfunction
- Date Received
- May 8, 2009
- Date of Event
- April 6, 2009
- Report Date
- April 16, 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
- FR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B) (4). (B) (4). INFROMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A CHOLECYSTECTOMY PROCEDURE, THERE WAS MALFORMED CLIPS, SCISSORED. THE PT LOST 500 ML OF BLOOD. NO BLOOD TRANSFUSION REQUIRED. THE BLEEDING WAS STOPPED AND THE PROCEDURE COMPLETED WITH THE USE OF ANOTHER LIKE DEVICE. THE PT IS FINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FZP CLIP, IMPLANTABLE | FZP | ETHICON ENDO-SURGERY, LLC | NA | F4MZ04 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |