FDA Adverse Event
Injury
Summary report: N
ENDOCLIP III 5MM APPLIER WITH HEMOSTAY CLIP
MDR report key: 2831004
·
Received November 2, 2012
Report
- Report Number
- 1219930-2012-00882
- Event Type
- Injury
- Date Received
- November 2, 2012
- Date of Event
- October 8, 2012
- Report Date
- October 17, 2012
- Manufacturer
- COVIDIEN, FORMERLY US SURGICAL
- Product Code
- FZP
- PMA / PMN Number
- 176630
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE TYPE: LAP CHOLE. ACCORDING TO THE REPORTER: DURING THE CASE EVERYTHING SEEMED FINE. THE PATIENT DEVELOPED A BILIARY PERITONITIS POST-OPERATIVELY. AN ERCP WAS PERFORMED ON (B)(6) AND EXPLORATORY LAP PERFORMED ON (B)(6) BUT THE SURGEON WAS UNABLE TO DETERMINE IF THE CLIPS WERE STILL IN PLACE OR NOT. THE PATIENT IS STILL HOSPITALIZED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDOCLIP III 5MM APPLIER WITH HEMOSTAY CLIP | DISPOSABLE CLIP APPLIER | FZP | COVIDIEN, FORMERLY US SURGICAL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 47 YR |