FDA Adverse Event
Malfunction
Summary report: N
LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER 20 MEDIUM-LARGE TITANIUM LIGA
MDR report key: 1112631
·
Received August 11, 2008
Report
- Report Number
- 3005075853-2008-01043
- Event Type
- Malfunction
- Date Received
- August 11, 2008
- Date of Event
- July 21, 2008
- Report Date
- July 21, 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
- FR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING AN UNK PROCEDURE, THE CLIPS DROPPED FROM THE APPLIER AND WHEN THEY ARE NORMALLY RELEASED, THEY DON'T HOLD. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER 20 MEDIUM-LARGE TITANIUM LIGA | FZP | ETHICON ENDO-SURGERY, LLC | NA | E4KW9C |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |