BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VASOVIEW ENDOSCOPIC VESSEL HARVESTING SYSTEM 6

    MDR report key: 1153071 · Received September 8, 2008

    Report

    Report Number
    2953148-2008-00778
    Event Type
    Injury
    Date Received
    September 8, 2008
    Date of Event
    August 13, 2008
    Report Date
    August 13, 2008
    Manufacturer
    GUIDANT CARDIAC SURGERY
    Product Code
    GEI
    PMA / PMN Number
    K041981
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS: THE VISUAL INSPECTION FOUND NO NON-CONFORMITIES. RESISTANCE MEASUREMENTS WERE WITHIN SPECIFICATIONS. FUNCTIONAL SIMULATED PRE-CAUTERY TESTING OF THE BISECTOR WAS PERFORMED WITH A REFERENCE VALLEY LAB GENERATOR POWER SOURCE. THE DEVICE FUNCTIONED WITH NO ELECTRICAL NON-CONFORMITIES FOUND. THE REPORTED FAILURE WAS NOT CONFIRMED. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE PRODUCT AND THERE WAS NO NONCONFORMANCE ASSOCIATED WITH THE LOT NUMBER.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING THE ENDOSCOPIC VEIN HARVESTING PROCEDURE, THREE BIPOLAR BISECTORS STOPPED CAUTERIZING. IT WOULD WORK DURING PRETEST AND IN THE BEGINNING OF THE PROCEDURE BUT AS THE HARVESTER PROGRESSED CAUTERIZING THE BRANCHES, THE BISECTOR AT SOME POINT WOULD NOT GENERATE HEAT. TROUBLESHOOTING CONSISTED OF CHANGING TWO VALLEY LAB GENERATORS AND THREE BIPOLAR CORDS. THE SURGEON CONVERTED TO OPEN LEG TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PATIENT COMPLICATIONS. THE HARVESTER WAS NOT YET EXPERIENCED AND HAD ONLY PERFORMED FOUR PREVIOUS CASES USING THE DEVICE. THIS REPORT IS FOR THE THIRD DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VASOVIEW ENDOSCOPIC VESSEL HARVESTING SYSTEM 6 GEI GUIDANT CARDIAC SURGERY VH-2000 8061071

    Patients

    Seq Age Sex Outcome Treatment
    1 NA