FDA Adverse Event
Injury
Summary report: N
STRYKER ULTRASONIC CURVED SHEARS
MDR report key: 2932221
·
Received January 22, 2013
Report
- Report Number
- MW5028716
- Event Type
- Injury
- Date Received
- January 22, 2013
- Date of Event
- January 10, 2013
- Report Date
- January 11, 2013
- Manufacturer
- STRYKER
- Product Code
- LFL
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- MD, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
PRODUCT WORKED IN AN INFERIOR MANNER. IT REQUIRED MULTIPLE TURNS TO CUT TISSUE. PRODUCT HAS DIFFERENT SHAPED CUTTING/COAGULATION PADS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 31546 | STRYKER ULTRASONIC CURVED SHEARS | NONE | LFL | STRYKER | 2179350 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR | Required Intervention |