BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUIDANT VASOVIEW 7XB

    MDR report key: 1151686 · Received August 18, 2008

    Report

    Report Number
    1151686
    Event Type
    Malfunction
    Date Received
    August 18, 2008
    Date of Event
    August 8, 2008
    Report Date
    August 18, 2008
    Manufacturer
    MAQUET CARDIOVASCULAR LLC
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT, US

    Narratives

    Description of Event or Problem · 1

    THE VASOVIEW DEVICE WAS USED FOR THE ENDOVEIN HARVESTING PROCEDURE DURING WHICH TIME THE CAUTERY/GRASPING INSTRUMENT WAS NOT FUNCTIONING CORRECTLY AND WOULD NOT GRASP THE TISSUE AS NECESSARY. A NEW VASOVIEW DISPOSABLE SET WAS OPENED AND USED WITHOUT FURTHER PROBLEMS.====================== MANUFACTURER RESPONSE FOR ENDOSCOPIC VESSEL HARVESTING SYSTEM, GUIDANT VASOVIEW 7XB======================MANUFACTURER PROVIDED RGA# FOR RETURN EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GUIDANT VASOVIEW 7XB VESSEL HARVESTING SYSTEM GCJ MAQUET CARDIOVASCULAR LLC VH-3200 8022571

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR