FDA Adverse Event
Malfunction
Summary report: N
SONCISION
MDR report key: 2933102
·
Received January 25, 2013
Report
- Report Number
- 2933102
- Event Type
- Malfunction
- Date Received
- January 25, 2013
- Date of Event
- December 12, 2012
- Report Date
- January 14, 2013
- Manufacturer
- COVIDIEN, FORMERLY VALLEYLAB, A DIVISION OF TYCO HEALTHCARE
- Product Code
- LFL
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- MO, US
Narratives
Description of Event or Problem · 1
SONICISION FAILED TO OPERATE. BATTERY AND GENERATOR CHANGED. DISPOSABLE WORKED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 36268 | SONCISION | INSTRUMENT, ULTRASONIC SURGICAL | LFL | COVIDIEN, FORMERLY VALLEYLAB, A DIVISION OF TYCO HEALTHCARE | SCD396 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR |