FDA Adverse Event
Injury
Summary report: N
PREMIUM SURGICLIP S-9.0 TITANIUM
MDR report key: 3232253
·
Received July 8, 2013
Report
- Report Number
- 2647580-2013-00373
- Event Type
- Injury
- Date Received
- July 8, 2013
- Report Date
- June 12, 2013
- Manufacturer
- COVIDIEN, FORMERLY USSC
- Product Code
- FZP
- PMA / PMN Number
- K853650
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PO
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE TYPE: VASCULAR. ACCORDING TO THE REPORTER: WHEN THE DEVICE IS CLAMPING AND WHEN RETRIEVED IT CUTS THE VESSEL AND NOT BEING ABLE TO CLAMP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 309100 | PREMIUM SURGICLIP S-9.0 TITANIUM | DISPOSABLE CLIP APPLIER | FZP | COVIDIEN, FORMERLY USSC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |