FDA Adverse Event
Injury
Summary report: N
ENDO CLIP 5MM CLIP APPLIER
MDR report key: 1893643
·
Received November 3, 2010
Report
- Report Number
- 1219930-2010-00826
- Event Type
- Injury
- Date Received
- November 3, 2010
- Date of Event
- July 1, 2010
- Report Date
- October 5, 2010
- Manufacturer
- UNITED STATES SURGICAL
- Product Code
- FZP
- PMA / PMN Number
- K954435
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
ACCORDING TO THE RPTR: AFTER THE OPERATION, THE PT SUFFERED A PERITONITIS, SINCE THE CLIPS DID NOT HOLD. THE PT WAS IN ICU FOR TWO MONTHS. NO ADDITIONAL INFO IS AVAILABLE AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDO CLIP 5MM CLIP APPLIER | DISPOSABLE CLIP APPLIER | FZP | UNITED STATES SURGICAL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization |