FDA Adverse Event
Injury
Summary report: N
VASOVIEW HEMOPRO
MDR report key: 3193411
·
Received June 21, 2013
Report
- Report Number
- MW5030656
- Event Type
- Injury
- Date Received
- June 21, 2013
- Date of Event
- June 17, 2013
- Report Date
- June 21, 2013
- Manufacturer
- MAQUET CARDIOVASCULAR, LLC
- Product Code
- GEI
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
PROBE ON ENDOSCOPIC VESSEL HARVESTING SYSTEM BEGAN TO EMIT SMOKE. WAS QUICKLY REMOVED FROM THE PT. UNABLE TO TURN OFF BROKE. PROBE DISCARDED AND ANOTHER PROBE USED WITHOUT COMPLICATIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 281828 | VASOVIEW HEMOPRO | VASOVIEW HEMOPRO ENDOSCOPIC VESSEL HARVESTING SYSTEM | GEI | MAQUET CARDIOVASCULAR, LLC | VH 3000 | 25077643 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Required Intervention |