FDA Adverse Event
Injury
Summary report: N
ENDO CLIP II MED/LRG 10MM PISTOL GRIP
MDR report key: 3232242
·
Received July 8, 2013
Report
- Report Number
- 1219930-2013-00516
- Event Type
- Injury
- Date Received
- July 8, 2013
- Date of Event
- June 13, 2013
- Report Date
- June 14, 2013
- Manufacturer
- COVIDIEN, FORMERLY UNITED STATES
- Product Code
- FZP
- PMA / PMN Number
- K954435
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
TRACKING NUMBER (B)(4).
Description of Event or Problem · 1
PROCEDURE: LADG - LAP ASSISTED DISTAL GASTRECTOMY. ACCORDING TO THE REPORTER: WHEN THE EXCISION ON THE LEFT GASTRIC ARTERY WAS PERFORMED, BLEEDING OCCURRED FROM UNDER THE CLIP ON THE PT SIDE. THE SURGEON CONSIDERS THE CLIP EDGE DAMAGED THE VESSEL WALL, RESULTING IN BLEEDING. THE VESSEL WAS LIGATED WITH SUTURE TO STOP THE BLEEDING. AMOUNT OF BLEEDING WAS LESS THAN 200 CC. THERE WAS NO UNANTICIPATED TISSUE LOSS. NOTHING FELL INTO CAVITY. PT IS UNDER OBSERVATION. OPERATING ROOM TIME NOT EXTENDED BY MORE THAN 30 MINUTES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 308724 | ENDO CLIP II MED/LRG 10MM PISTOL GRIP | DISPOSABLE CLIP APPLIER | FZP | COVIDIEN, FORMERLY UNITED STATES |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR | Other |