FDA Adverse Event
Injury
Summary report: N
ENDOCLIP III 5MM APPLIER W/HEMOSTAY CLIP
MDR report key: 3232235
·
Received July 8, 2013
Report
- Report Number
- 1219930-2013-00517
- Event Type
- Injury
- Date Received
- July 8, 2013
- Date of Event
- May 23, 2013
- Report Date
- June 17, 2013
- Manufacturer
- COVIDIEN, FORMERLY US SURGICAL
- Product Code
- FZP
- PMA / PMN Number
- K071406
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHARMACIST
Narratives
Additional Manufacturer Narrative · 1
TRACKING NUMBER (B)(4).
Description of Event or Problem · 1
PROCEDURE: CHOLECYSTECTOMY. ACCORDING TO THE REPORTER: THE 6TH CLIP DIDN'T COME OUT. THERE WAS BLOOD LOSS OF APPROX 300ML. THE SURGEON CONVERTED THE PROCEDURE. THE PT STAYED LONGER AT THE HOSPITAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 309093 | ENDOCLIP III 5MM APPLIER W/HEMOSTAY CLIP | DISPOSABLE CLIP APPLIER | FZP | COVIDIEN, FORMERLY US SURGICAL | N2M0888LX |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| O| R |