FDA Adverse Event
Injury
Summary report: N
ENDOCLIP III 5MM APPLIER W/ HEMOSTAY CLIP
MDR report key: 3787047
·
Received April 25, 2014
Report
- Report Number
- 1219930-2014-00326
- Event Type
- Injury
- Date Received
- April 25, 2014
- Date of Event
- March 24, 2014
- Report Date
- April 8, 2014
- Manufacturer
- COVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES
- Product Code
- GDO
- PMA / PMN Number
- K061288
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE TYPE: LAP CHOLE. ACCORDING TO THE REPORTER: ENDO CLIP III WAS USED AND PATIENT WENT HOME. PT CAME BACK ON 26TH COMPLAINING OF ABDOMINAL PAIN. MRI WAS DONE AND PATIENT WAS HAVING BILE LEAK. CAT SCAN IN EMERGENCY ERCP. DR. (B)(6) THAT USED ENDO CLIP III) THINKS THAT CLIP CAME LOOSE CAUSING BILE LEAK, BUT THERE IS NO EVIDENCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 250495 | ENDOCLIP III 5MM APPLIER W/ HEMOSTAY CLIP | DISPOSABLE CLIP APPLIER | GDO | COVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES | 176630 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |