FDA Adverse Event
Summary report: N
ECS 25MM STAPLER
MDR report key: 3001709
·
Received March 8, 2013
Report
- Report Number
- MW5029326
- Date Received
- March 8, 2013
- Date of Event
- February 28, 2013
- Report Date
- March 1, 2013
- Manufacturer
- ETHICON
- Product Code
- GDW
- Report Source
- Voluntary report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Description of Event or Problem · 1
ROBOTIC ASSISTED LAP CONVERTED TO OPEN SIGMOIDECTOMY DUE TO MALFUNCTION OF STAPLER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 98619 | ECS 25MM STAPLER | GDW | ETHICON | F5VY5C 1043 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Required Intervention |