FDA Adverse Event
Injury
Summary report: N
ENDO GIA UNIVERSAL 12 MM SINGLE USE INST
MDR report key: 2974180
·
Received February 12, 2013
Report
- Report Number
- 1219930-2013-00088
- Event Type
- Injury
- Date Received
- February 12, 2013
- Date of Event
- November 28, 2012
- Report Date
- January 23, 2013
- Manufacturer
- COVIDIEN, FORMERLY US SURGICAL
- Product Code
- GDW
- PMA / PMN Number
- K061095
- 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
PROCEDURE: PELVIC. ACCORDING TO THE REPORTER: DURING APPLICATION ON A RECTUM, THE DEVICES CUT THE TISSUE BUT DID NOT STAPLE. SOME FECES WENT INTO DIRECT CONTACT WITH THE PELVIS. THE SURGERY HAD TO BE CHANGED TO AN OPEN SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 62221 | ENDO GIA UNIVERSAL 12 MM SINGLE USE INST | DISPOSABLE STAPLER | GDW | COVIDIEN, FORMERLY US SURGICAL | N2E0679X |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | ENDO GIA ROTICULATOR 60-3.5 SULU,| 030458, LOT # N2K0602LX,| EXP DATE: 10/31/2017, MFR DATE: 10/2012 |