FDA Adverse Event
Injury
Summary report: N
VASOVIEW HEMOPRO
MDR report key: 2150754
·
Received June 30, 2011
Report
- Report Number
- MW5021223
- Event Type
- Injury
- Date Received
- June 30, 2011
- Date of Event
- June 23, 2011
- Report Date
- June 23, 2011
- Manufacturer
- MAQUET CARDIOVASCULAR
- Product Code
- GEI
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- FL, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
ENDOSCOPIC VEIN HARVEST-INSULATION TIP TORE FROM TIP OF DEVICE DURING PROCEDURE. (TWO PRODUCTS WITH SAME LOT NUMBER).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VASOVIEW HEMOPRO | ENDOSCOPIC VESSEL HARVESTING SYSTEM | GEI | MAQUET CARDIOVASCULAR | VH-3000 | 25025389 | |
| 2 | VASOVIEW HEMOPRO | ENDOSCOPIC VESSEL HARVESTING SYSTEM | GEI | MAQUET CARDIOVASCULAR | VH-3000 | 25025389 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Required Intervention |