FDA Adverse Event
Malfunction
Summary report: N
COVIDIEN LIGASURE IMPACT INSTRUMENT
MDR report key: 2921433
·
Received January 15, 2013
Report
- Report Number
- 2921433
- Event Type
- Malfunction
- Date Received
- January 15, 2013
- Date of Event
- December 12, 2012
- Report Date
- January 15, 2013
- Manufacturer
- STRYKER SUSTAINABILITY SOLUTIONS
- Product Code
- GEI
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- NV, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
WHILE ATTEMPTING TO USE, THE EQUIPMENT STUCK WHEN MD TRIED TO RELEASE. HAD TO CALL AND USE BACK-UP EQUIPMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 22060 | COVIDIEN LIGASURE IMPACT INSTRUMENT | ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | GEI | STRYKER SUSTAINABILITY SOLUTIONS | * | 2073593 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR |