FDA Adverse Event
Malfunction
Summary report: N
*
MDR report key: 3003764
·
Received February 21, 2013
Report
- Report Number
- 3003764
- Event Type
- Malfunction
- Date Received
- February 21, 2013
- Report Date
- January 21, 2013
- Manufacturer
- ETHICON ENDO-SURGERY, INC.
- Product Code
- GAG
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- MT, US
Narratives
Description of Event or Problem · 1
DEVICE DID NOT FIRE CORRECTLY, THE STAPLES WERE "LOOSE" ON THE STOMACH.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?STAPLE THE STOMACH INCISION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 75267 | * | STAPLER, SURGICAL | GAG | ETHICON ENDO-SURGERY, INC. | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 37 YR |