FDA Adverse Event
Injury
Summary report: N
ENDO CLIP II MED/LRG 10MM PISTOL GRIP
MDR report key: 2831026
·
Received November 2, 2012
Report
- Report Number
- 1219930-2012-00888
- Event Type
- Injury
- Date Received
- November 2, 2012
- Date of Event
- October 16, 2012
- Report Date
- October 26, 2012
- Manufacturer
- COVIDIEN, FORMERLY US SUR
- Product Code
- FZP
- PMA / PMN Number
- K954435
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VE
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
ACCORDING TO THE REPORTER: IT HAPPENS QUITE OFTEN THAT AFTER FIRING A CLIP A NEW CLIP IS NOT LOADED LEAVING THE JAWS EMPTY. IF THIS HAPPENS AT THE SAME TIME THE CLIP APPLIER IS FIRED ON A BLOOD VESSEL A VESSEL IS TORN WITH THE CONSEQUENT OF BLEEDING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDO CLIP II MED/LRG 10MM PISTOL GRIP | DISPOSABLE CLIP APPLIER | FZP | COVIDIEN, FORMERLY US SUR | N0M0635 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |