FDA Adverse Event
Malfunction
Summary report: N
LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER 20 LARGE TITANIUM LIGATING
MDR report key: 1080528
·
Received July 24, 2008
Report
- Report Number
- 3005075853-2008-00441
- Event Type
- Malfunction
- Date Received
- July 24, 2008
- Date of Event
- June 9, 2008
- Report Date
- June 18, 2008
- Manufacturer
- ETHICON ENDO-SURGERY, LLC
- Product Code
- FZP
- PMA / PMN Number
- K864102
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KN
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
H4, 6: INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A NEPHRECTOMY PROCEDURE, BEFORE USING THE DEVICE, A RIBBON-SHAPED MALFORMED CLIP WAS FOUND STUCK IN THE SHAFT. THE DEVICE WAS TEST FIRED AND THE OTHER CLIP POPPED OFF FROM THE JAW. THE PROCEDURE WAS EXTENDED BY TEN MINUTES. THERE WAS NO ADVERSE PT CONSEQUENCE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER 20 LARGE TITANIUM LIGATING | NONE | FZP | ETHICON ENDO-SURGERY, LLC | NA | D4MY4V |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |