FDA Adverse Event
Malfunction
Summary report: N
LINEAR, TL60
MDR report key: 2348808
·
Received November 21, 2011
Report
- Report Number
- 2348808
- Event Type
- Malfunction
- Date Received
- November 21, 2011
- Date of Event
- October 27, 2011
- Report Date
- November 21, 2011
- Manufacturer
- ETHICON ENDO-SURGERY, INC.
- Product Code
- GDW
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- MO, US
Narratives
Description of Event or Problem · 1
STAPLER FAILED TO CLOSE FOR DOCTOR. DEVICE PLACED ON RESOURCE DESK. DELIVERED TO MATERIALS FOR EVALUATION AND REPLACEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LINEAR, TL60 | STAPLER, LINEAR, SURGICAL | GDW | ETHICON ENDO-SURGERY, INC. | TL60 | 1144D02 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |