FDA Adverse Event
Malfunction
Summary report: N
LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER 20 LARGE TITANIUM LIGATING CL
MDR report key: 1122047
·
Received August 14, 2008
Report
- Report Number
- 3005075853-2008-01223
- Event Type
- Malfunction
- Date Received
- August 14, 2008
- Date of Event
- July 24, 2008
- Report Date
- July 30, 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
- IT
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
D4, H4, H6: INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING AN UNK PROCEDURE, THE FIRST FIVE CLIPS FIRED FELL OUT FROM THE JAWS WITH THEIR LEG CROSSED. THE PROCEDURE WAS CARRIED OUT AND FINISHED BY USING ANOTHER DEVICE. NO ADVERSE PT CONSEQUENCES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER 20 LARGE TITANIUM LIGATING CL | FZP | ETHICON ENDO-SURGERY, LLC | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |