FDA Adverse Event
Malfunction
Summary report: N
LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER 20
MDR report key: 731940
·
Received June 22, 2006
Report
- Report Number
- 1527736-2006-02841
- Event Type
- Malfunction
- Date Received
- June 22, 2006
- Date of Event
- May 30, 2006
- Report Date
- May 31, 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
- UK
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
DATE SENT: 06/22/2006.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE CLIPS WOULD NOT CLOSE SECURELY ON VESSELS, LEADING TO CLIPS FALLING AWAY FROM THE VESSELS. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.
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 | C4DM0L |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |