BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO

    MDR report key: 2771655 · Received August 29, 2012

    Report

    Report Number
    2771655
    Event Type
    Malfunction
    Date Received
    August 29, 2012
    Date of Event
    July 20, 2012
    Report Date
    August 29, 2012
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    MAQUET VASOVIEW HEMOPRO ENDOSCOPIC VESSEL HARVESTING SYSTEM WAS USED. THERE ARE TWO COMPONENTS: VASOVIEW HARVESTING CANNULA AND VASOVIEW HEMOPRO HARVESTING TOOL.WHILE IN USE, THE HARVESTING TOOL BECAME STUCK IN THE "ON" POSITION. THE TOOL WAS INSIDE OF THE PATIENT'S RIGHT UPPER LEG. SMOKE WAS NOTICED INSIDE OF THE LEG WHILE DIRECTLY VIEWING ENDOSCOPICALLY. THE TOOL WAS REMOVED. SMOKE WAS SEEN COMING OUT OF THE DISTAL PORTION OF THE TOOL. THE TOOL WAS DISCONNECTED FROM THE LIGHT SOURCE, HEMOPRO POWER SUPPLY AND THE STORZ (ENDOSCOPE) UNIT. THIS TOOL WAS IMMEDIATELY REMOVED FROM THE FIELD AND A NEW HARVESTING SYSTEM WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VASOVIEW HEMOPRO ELECTROSURGICAL, CUTTING AND COAGULATION AND ACCESSORIES GEI MAQUET CARDIOVASCULAR, LLC * 25058543

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR