FDA Adverse Event
Injury
Summary report: N
ENDO CLIP LRGE 10MM PISTOL GRIP APPLIER
MDR report key: 2644890
·
Received June 28, 2012
Report
- Report Number
- 1219930-2012-00545
- Event Type
- Injury
- Date Received
- June 28, 2012
- Date of Event
- June 6, 2012
- Report Date
- June 11, 2012
- Manufacturer
- COVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES
- Product Code
- FZP
- PMA / PMN Number
- K954435
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE TYPE: COLECTOMY. ACCORDING TO THE REPORTER: ALL CLIPS WERE NOT PROPERLY FORMED, AND APPEARED TO BE SCISSORED. THE SCISSORED CLIPS CUT THE VESSEL BUT NO IRREVERSIBLE DAME HAPPENED SINCE THE SURGEON CLOSED THE VESSEL WITH OTHER CLIPS. THE SURGEON USED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. OPERATING ROOM TIME WAS EXTENDED ABOUT 30 MINUTES BUT NOT MORE. THERE WAS NO BLEEDING OVER 250CC.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDO CLIP LRGE 10MM PISTOL GRIP APPLIER | DISPOSABLE CLIP APPLIER | FZP | COVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES | N1A0108 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |