FDA Adverse Event
Malfunction
Summary report: N
LIGACLIP ENDSCOPIC ROTATING MULTIPLE CLIP APPLIER 20 LARGE TITANIUM LIGATING CLI
MDR report key: 1162315
·
Received September 8, 2008
Report
- Report Number
- 3005075853-2008-01566
- Event Type
- Malfunction
- Date Received
- September 8, 2008
- Date of Event
- August 14, 2008
- Report Date
- August 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
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
D4; H4, 6: INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A CHOLECYSTECTOMY PROCEDURE, SOME CLIPS WERE EJECTED BEFORE USE ON THE PT. CLIPS ALSO FELL INTO THE OPERATIVE FIELD DURING THE OPERATION. ANOTHER NEW 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 ENDSCOPIC ROTATING MULTIPLE CLIP APPLIER 20 LARGE TITANIUM LIGATING CLI | FZP | ETHICON ENDO-SURGERY, LLC. | NA | D4G92H |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |