FDA Adverse Event
Injury
Summary report: N
ENDO GIA ROTICULATOR 60-3.5 SULU
MDR report key: 3054734
·
Received April 8, 2013
Report
- Report Number
- 1219930-2013-00259
- Event Type
- Injury
- Date Received
- April 8, 2013
- Report Date
- March 14, 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
- GM
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE TYPE: SIGMOIDECTOMY. ACCORDING TO EUR SURG RES 2012; 49:130 - 216 - (B)(6) - CITATION 163: SINGLE INCISION LAPAROSCOPIC SIGMOIDECTOMY: RESULTS AFTER (B)(4) PROCEDURES: SIGMOIDECTOMY VIA SILS. IN THE PELVIS, THE PERITONEUM AND MESO WERE DIVIDED IN THE RECTOSIGMOID AREA (ENDO GIA 60 - 35 ARTICULATING INSTRUMENT). THE CITATION REPORTED ON ANASTOMOTIC LEAK AS A MAJOR COMPLICATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 142477 | ENDO GIA ROTICULATOR 60-3.5 SULU | DISPOSABLE SURGICAL STAPLING DEVICE | GDW | COVIDIEN, FORMERLY US SURGICAL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |