BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW ENDOSCOPIC VESSEL HARVESTING SYSTEM 6

    MDR report key: 1191874 · Received October 1, 2008

    Report

    Report Number
    2953148-2008-00821
    Event Type
    Malfunction
    Date Received
    October 1, 2008
    Date of Event
    September 8, 2008
    Report Date
    September 12, 2008
    Manufacturer
    GUIDANT CARDIAC SURGERY
    Product Code
    GEI
    PMA / PMN Number
    K041981
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS: INVESTIGATION WAS COMPLETED AND THE DEVICE PASSED THE ELECTRICAL SPECIFICATIONS, AND THE SIMULATED CAUTERY TEST. THE COMPLAINT IS NOT CONFIRMED FOR THE DEVICE WOULD NOT CAUTERIZE. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORD DID NOT REVEAL ANY NON CONFORMANCE REPORTS, WHICH COULD HAVE CONTRIBUTED TO THIS COMPLAINT.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING THE ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE DEVICE WOULD NOT CAUTERIZE. A REPLACEMENT DEVICE AND BOVIE CORD WAS USED TO COMPLETE THE PROCEDURE. NO PT COMPLICATIONS WERE REPORTED BY THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VASOVIEW ENDOSCOPIC VESSEL HARVESTING SYSTEM 6 GEI GUIDANT CARDIAC SURGERY VH-2000 8062871

    Patients

    Seq Age Sex Outcome Treatment
    1 NA