FDA Adverse Event
Injury
Summary report: N
ENDO CLIP II MED/LRG 10MM PISTOL GRIP
MDR report key: 3030649
·
Received March 25, 2013
Report
- Report Number
- 1219930-2013-00173
- Event Type
- Injury
- Date Received
- March 25, 2013
- Date of Event
- February 27, 2013
- Report Date
- February 28, 2013
- Manufacturer
- COVIDIEN, FORMERLY US
- Product Code
- FZP
- PMA / PMN Number
- K954435
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE TYPE: SIGMOIDECTOMY. ACCORDING TO THE REPORTER: AFTER APPLIED ON THE VESSEL, THE CLIP SPLIT IN TWO WITH A POP. HALF OF THE CLIP WAS RETRIEVED, BUT THE OTHER HALF WAS NOT FOUND. THE SURGEON CONTINUED TO USE THE DEVICE, AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER PROBLEM. THERE WAS NO BLEEDING REPORTED IN EXCESS OF 500CC. THERE WAS NO UNANTICIPATED TISSUE LOSS. THE CASE WAS NOT EXTENDED BY MORE THAN 30 MINUTES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 121514 | ENDO CLIP II MED/LRG 10MM PISTOL GRIP | DISPOSABLE CLIP APPLIER | FZP | COVIDIEN, FORMERLY US |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |