FDA Adverse Event
Injury
Summary report: N
ENDO CLIP 5MM CLIP APPLIER
MDR report key: 2232504
·
Received August 25, 2011
Report
- Report Number
- 1219930-2011-00722
- Event Type
- Injury
- Date Received
- August 25, 2011
- Report Date
- August 15, 2011
- Manufacturer
- UNITED STATES SURGICAL
- Product Code
- FZP
- PMA / PMN Number
- K954435
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE: LAP CHOLE. ACCORDING TO THE REPORTER: DURING SURGERY, THE DEVICE FAILED, IT DIDN'T LEAVE THE CLIP IN THE ZONE THAT IT WAS SUPPOSED TO, PRODUCING DAMAGE TO THE CYSTIC DUCT AND ARTERY. THE TISSUE WAS REPAIRED USING ANOTHER PRODUCT. THE PT IS IN PERFECT CONDITION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDO CLIP 5MM CLIP APPLIER | DISPOSABLE CLIP APPLIER | FZP | UNITED STATES SURGICAL | N1A0536 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |