FDA Adverse Event
Malfunction
Summary report: N
SNOWDEN-PENCER
MDR report key: 1609760
·
Received February 10, 2010
Report
- Report Number
- 1609760
- Event Type
- Malfunction
- Date Received
- February 10, 2010
- Date of Event
- February 8, 2010
- Report Date
- February 10, 2010
- Manufacturer
- CAREFUSION 2200, INC.
- Product Code
- GCJ
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- AR, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
TINE BROKE OFF GRASPER. PIECE WAS RETRIEVED BY PHYSICIAN. NO PATIENT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SNOWDEN-PENCER | LAPAROSCOPIC GRASPER | GCJ | CAREFUSION 2200, INC. | * | B02R1 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR |