BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW 7 XB EVH SYSTEM

    MDR report key: 1934184 · Received December 8, 2010

    Report

    Report Number
    2242352-2010-03539
    Event Type
    Malfunction
    Date Received
    December 8, 2010
    Date of Event
    November 5, 2010
    Report Date
    November 9, 2010
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    GEI
    PMA / PMN Number
    K041981
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: A VISUAL INSPECTION REVEALED THAT THERE WERE NO NON CONFORMITIES WITH THE DEVICE AND MINIMAL SIGNS OF USAGE AND BLOOD. A FUNCTIONAL TEST WAS PERFORMED ON THE DEVICE WITH A REFERENCE GENERATOR AND BIPOLAR CORD. THE DEVICE PASSED THE FUNCTIONAL TEST, IT GENERATED STEAM AND HEAT. BASED UPON THIS, THE REPORTED FAILURE "FAILURE TO DELIVER ENERGY" COULD NOT BE CONFIRMED. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE PRODUCT. THERE WAS NO NONCONFORMANCE WHICH COULD HAVE CONTRIBUTED TO THIS FAILURE MODE. (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, WHEN THE BISECTOR WAS ACTIVATED, IT DID NOT WORK. A NEW KIT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PT EFFECTS. THE PRODUCT WAS RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VASOVIEW 7 XB EVH SYSTEM ENDOSCOPIC VESSEL HARVESTING SYSTEM GEI MAQUET CARDIOVASCULAR, LLC VH-3200 25021383

    Patients

    Seq Age Sex Outcome Treatment
    1 NA