BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO 2

    MDR report key: 1981478 · Received January 14, 2011

    Report

    Report Number
    1981478
    Event Type
    Malfunction
    Date Received
    January 14, 2011
    Date of Event
    January 10, 2011
    Report Date
    January 14, 2011
    Manufacturer
    MAQUET CARDIOVASCULAR LLC
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHILE USING MAQUET ENDOSCOPIC VEIN HARVESTING (EVH) SYSTEM, SMOKE WAS NOTED AT THE DISTAL TIP OF INSTRUMENT DURING INSERTION INTO THE HARVESTING CANNULA. THE FIRST ASSISTANT NOTED SMOKE ON THE MONITOR AND WITHDREW THE INSTRUMENT. NO DIRECT CONTACT WITH PATIENT AND NO HARM TO PATIENT. EQUIPMENT SEQUESTERED AND ANOTHER MAQUET INSTRUMENT OPENED FOR EVH PROCEDURE.STAFF NOTED THAT THE SMALL WIRE ON THE JAW WAS MISALIGNED. DEVICE STARTED SMOKING 5 MINUTES AFTER CASE HAD STARTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VASOVIEW HEMOPRO 2 ENDOSCOPIC VESSEL HARVESTING SYSTEM GEI MAQUET CARDIOVASCULAR LLC * 25023047

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR CARDIAC DRUGS