FDA Adverse Event
Injury
Summary report: N
ENDO GIA UNIVERSAL 12MM SINGLE USE INST
MDR report key: 2831033
·
Received November 2, 2012
Report
- Report Number
- 1219930-2012-00887
- Event Type
- Injury
- Date Received
- November 2, 2012
- Date of Event
- October 11, 2012
- Report Date
- October 12, 2012
- Manufacturer
- COVIDIEN, FORMERLY US SUR
- Product Code
- GDW
- PMA / PMN Number
- K061095
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE: GASTRECTOMY. ACCORDING TO THE REPORTER: STAPLE LINES DID NOT FORM PROPERLY. SURGEON HAD TO CONVERT FROM LAPAROSCOPIC TO OPEN TO COMPLETE THE GASTRECTOMY USING SUTURE. DELAY IN THE PROCEDURE WAS MORE THAN 30 MINUTES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDO GIA UNIVERSAL 12MM SINGLE USE INST | NONE | GDW | COVIDIEN, FORMERLY US SUR | N2F0073X |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | Required Intervention | DATE 12/2011| ENDO GIA ROTICULATOR* 45-3.5 SULU: 030455| LOT N1M0279L, EXPIRATION 12/31/2016, MANUFACTURE |