FDA Adverse Event
Malfunction
Summary report: N
LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APLIER 20 MEDIUM-LARGE TITANIUM LIGAT
MDR report key: 1516024
·
Received October 19, 2009
Report
- Report Number
- 3005075853-2009-06298
- Event Type
- Malfunction
- Date Received
- October 19, 2009
- Date of Event
- August 12, 2009
- Report Date
- October 13, 2009
- 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
- AS
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DATE SENT: 10/19/2009. INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE CLIPS WERE NOT ADVANCING, WERE FALLING OUT AND WERE SCISSORING. IT WAS NOT REPORTED HOW THE PROCEDURE WAS COMPLETED. 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 APLIER 20 MEDIUM-LARGE TITANIUM LIGAT | FZP CLIP, IMPLANTABLE | FZP | ETHICON ENDO-SURGERY, LLC | NA | F4N3WN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |