FDA Adverse Event
Injury
Summary report: N
ETHICON ENDOSURGERY LLC
MDR report key: 5267518
·
Received December 2, 2015
Report
- Report Number
- MW5058286
- Event Type
- Injury
- Date Received
- December 2, 2015
- Manufacturer
- ETHICON ENDOSURGERY LLC
- Product Code
- GDW
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- TX, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
A (B)(6) HISTORY OF GERD. ADMITTED ON (B)(6) 2015 DUE TO WEAKNESS AND FATIGUE. S/P COLONOSCOPY WITH FUNGATING MASS IN CECUM, + ADENOCARCINOMA, (B)(6) 2015 LAP ASSIST RIGHT HEMICOLECTOMY WITH ILEOCOLONIC ANASTOMOSIS. POD #4 + BANDEMIA. POD #5 CT FREE FLUID; (B)(6) 2015 TO OPERATING ROOM DUE TO ANASTOMOTIC FAILURE MIDDLE OF POSTERIOR STAPLE LINE (LEAK/BROKE DOWN SUTURES), STAPLE ITSELF WAS SEPARATED. REINFORCED IN SURGERY. DISCHARGED HOME TO F/U WITH ONCOLOGY AND WOUND CARE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 792920 | ETHICON ENDOSURGERY LLC | STAPLER 5MM | GDW | ETHICON ENDOSURGERY LLC | M4HT45 | ||
| 792921 | ETHICON ENDOSURGERY LLC | LINER CUTTER RELOAD 75MM | GDW | ETHICON ENDOSURGERY LLC | M4HH6R | ||
| 792922 | ETHICON ENDOSURGERY LLC | LINEAR CUTTER RELOAD 75MM | GDW | ETHICON ENDOSURGERY LLC | M4HJ1V | ||
| 792923 | ETHICON ENDOSURGERY LLC | LINEAR STAPLER | GDW | ETHICON ENDOSURGERY LLC | M4H95Y |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Hospitalization |