FDA Adverse Event
Injury
Summary report: N
ENDO CLIP II MED/LRG 10MM PISTOL GRIP
MDR report key: 3041992
·
Received April 2, 2013
Report
- Report Number
- 9612501-2013-00025
- Event Type
- Injury
- Date Received
- April 2, 2013
- Date of Event
- February 28, 2013
- Report Date
- March 12, 2013
- Manufacturer
- COVIDIEN
- Product Code
- FZP
- PMA / PMN Number
- K954435
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TU
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE TYPE: LAPAROSCOPIC CHOLECYSTECTOMY. ACCORDING TO THE REPORTER: DURING THE PROCEDURE, THE TISSUE MOVED FORWARD WHILE TRYING TO APPLY THE CLIP, WHICH RESULTED IN DAMAGE TO THE TISSUE. SOME CLIPS WERE APPLIED AND CLOSED CROSSWIRE. DURING THIS PERIOD CROSS CLIPS WERE TAKEN OFF AND REAPPLIED. THE CLIPS FELL INTO THE PATIENT'S CAVITY AND WERE RETRIEVED BY HAND INSTRUMENTS. THERE WAS NO BLEEDING REPORTED IN EXCESS OF 250CC. THE CASE WAS EXTENDED BY MORE THAN 30 MINUTES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 134166 | ENDO CLIP II MED/LRG 10MM PISTOL GRIP | DISPOSABLE CLIP APPLIER | FZP | COVIDIEN | J2F0024X |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |