BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW 6 EVH SYSTEM

    MDR report key: 2093408 · Received April 12, 2011

    Report

    Report Number
    2242352-2011-00336
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Date of Event
    March 11, 2011
    Report Date
    March 14, 2011
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC.
    Product Code
    GEI
    PMA / PMN Number
    K041981
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: VISUAL INSPECTION REVEALED THAT THERE WERE NO NON CONFORMITIES WITH THE DEVICE. THERE WAS SOME EVIDENCE OF BLOOD. A FUNCTIONAL TEST WAS PERFORMED ON THE DEVICE WITH 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. INTERNAL FILE NUMBER - (B)(4).

    Description of Event or Problem · 1

    THE HOSP REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE VASOVIEW 6 CAUTERY WOULD NOT COME ON AT ALL WHEN THEY STARTED. 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 6 EVH SYSTEM ENDOSCOPIC VESSEL HARVESTING SYSTEM GEI MAQUET CARDIOVASCULAR, LLC. VH-2000 25028372

    Patients

    Seq Age Sex Outcome Treatment
    1 NA