BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO ENDOSCOPIC VESSEL HARVESTING

    MDR report key: 2932306 · Received January 21, 2013

    Report

    Report Number
    MW5028728
    Event Type
    Malfunction
    Date Received
    January 21, 2013
    Date of Event
    January 16, 2013
    Report Date
    January 21, 2013
    Manufacturer
    MARQUET CARDIOVASCULAR
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    DURING ENDOSCOPIC VEIN HARVEST WITH VASOVIEW SYSTEM, BURNING OF DRAPES NOTED AS SCOPE WITH CAUTERY "MECH" INCLUDED WAS SITTING IN THE DRAPE POCKET AND BURNING OF DRAPE NOTED. UNIT REMOVED FROM POCKET AND CAUTERY TIP WAS GLOWING. CAUTERY UNIT DISCONNECTED FROM UNIT ON TOWER. NOTED THAT THE CAUTERY CORD CONNECTION WAS NOT COMPLETELY SEATED AT CONNECTION WHEN DISMANTLING UNIT. EQUIPMENT CHANGED OUT. DIAGNOSIS OR REASON FOR USE: ANGINA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28820 VASOVIEW HEMOPRO ENDOSCOPIC VESSEL HARVESTING VASOVIEW VH3000 GEI MARQUET CARDIOVASCULAR VH3000 25068688

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR