FDA Adverse Event
Malfunction
Summary report: N
DIRECT DRIVE DISPOSAL LAPAROSCOPIC CLIP APPLIER
MDR report key: 1811270
·
Received August 13, 2010
Report
- Report Number
- 1811270
- Event Type
- Malfunction
- Date Received
- August 13, 2010
- Report Date
- December 30, 2009
- Manufacturer
- APPLIED MEDICAL
- Product Code
- GDO
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- TX, US
Narratives
Description of Event or Problem · 1
DEVICE DID NOT FUNCTION PROPERLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DIRECT DRIVE DISPOSAL LAPAROSCOPIC CLIP APPLIER | CLIP APPLIER | GDO | APPLIED MEDICAL | * | 1098805 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 38 YR |