BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO

    MDR report key: 1781428 · Received July 30, 2010

    Report

    Report Number
    1781428
    Event Type
    Malfunction
    Date Received
    July 30, 2010
    Date of Event
    July 28, 2010
    Report Date
    July 30, 2010
    Manufacturer
    MAQUET CARDIOVASCULAR LLC
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE VEIN HARVESTER WAS PULLED OUT OF THE LEG AND IT WAS DISCOVERED THAT THE INSULATION ON THE TIP WAS PULLED BACK AND OFF THE TIP. NOTHING CAME OFF COMPLETELY SO THERE IS NOTHING LEFT IN THE PATIENT.====================== MANUFACTURER RESPONSE FOR ENDOSCOPIC VESSEL HARVESTING SYSTEM======================THEY ARE GIVING INFORMATION TO THE QUALITY DEPARTMENT, SENDING OUT AN RMA AND RETURN BIOHAZARD BAG, AND SENDING A REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VASOVIEW HEMOPRO ENDOSCOPIC VESSEL HARVESTING SYSTEM GEI MAQUET CARDIOVASCULAR LLC VH 3000 25006138

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR