FDA Adverse Event
Malfunction
Summary report: N
LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER 20
MDR report key: 725898
·
Received June 8, 2006
Report
- Report Number
- 1527736-2006-02616
- Event Type
- Malfunction
- Date Received
- June 8, 2006
- Date of Event
- June 5, 2006
- Report Date
- June 6, 2006
- Manufacturer
- ETHICON ENDO-SURGERY, INC.(CINCINNATI)
- Product Code
- FZP
- PMA / PMN Number
- K864102
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. 510(K) IS K864102
Description of Event or Problem · 1
DURING A CHOLECYSTECTOMY PROCEDURE, COULD NOT HOLD CLIPS AT THE THIRD FIRING. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PT. NO DEVICE RETURNING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER 20 | FZP | FZP | ETHICON ENDO-SURGERY, INC.(CINCINNATI) | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |