FDA Adverse Event
Malfunction
Summary report: N
AUTO SUTURE
MDR report key: 1613743
·
Received February 19, 2010
Report
- Report Number
- MW5014868
- Event Type
- Malfunction
- Date Received
- February 19, 2010
- Report Date
- October 1, 2008
- Product Code
- GDW
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
STAPLER NOT WORKING. DIDN'T OPEN. NOT USED ON PT. FAXED ON 02/19/2010.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AUTO SUTURE | ENDO GIA UNIVERSAL | GDW | 030449 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 18 YR |