FDA Adverse Event
Summary report: N
*
MDR report key: 2822469
·
Received October 23, 2012
Report
- Report Number
- 2822469
- Date Received
- October 23, 2012
- Date of Event
- October 8, 2012
- Report Date
- October 23, 2012
- Manufacturer
- ETHICON ENDO-SURGERY, INC.
- Product Code
- GDW
- Report Source
- User Facility report
- Reporter Location
- CA, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
THE STAPLER DID NOT DO WHAT IT WAS SUPPOSED TO DO. A LEAK WAS NOTED, SO A NEW STAPLER WAS USED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | * | ENDOSCOPIC CURVED INTRALUMINAL STAPLER | GDW | ETHICON ENDO-SURGERY, INC. | ECS29A | J4C82U |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | NONE KNOWN |