BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO ENDOSCOPIC VESSEL HARVESTING SYSTEM

    MDR report key: 1213757 · Received October 22, 2008

    Report

    Report Number
    2953148-2008-00866
    Event Type
    Malfunction
    Date Received
    October 22, 2008
    Date of Event
    October 1, 2008
    Report Date
    October 1, 2008
    Manufacturer
    GUIDANT CARDIAC SURGERY
    Product Code
    GEI
    PMA / PMN Number
    K052274
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS: A VISUAL INSPECTION SHOWED NO NON-CONFORMANCES WERE FOUND WITH THE HOT JAW BOOT OR THE COLD JAW BOOT. THE HEMOPRO DEVICE WAS TESTED TO VERIFY THE FUNCTIONALITY BY CONNECTING IT TO A REFERENCE POWER SUPPLY, THEN THE DEVICE WAS REPEATEDLY TURNED ON AND OFF WHILE THE JAWS WERE WEDGED INTO A SALINE SOAKED GAUZE PAD. DUE TO THE STEAMING AND SPUTTERING COMING FROM THE CLOSED HEMOPRO JAWS, IT WAS CONCLUDED THAT THE DEVICE WAS FUNCTIONING CORRECTLY. THE REPORTED FAILURE WAS NOT CONFIRMED. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE PRODUCT. THERE WAS NO NONCONFORMANCE WHICH COULD HAVE ATTRIBUTED TO THIS FAILURE MODE.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE HEMOPRO TISSUE WELDER'S JAW BOOT BROKE OFF IN THE PATIENT'S LEG AND HAD TO BE RETRIEVED. NO ADDITIONAL INCISION WAS REQUIRED. THE HARVESTER USED ANOTHER HEMOPRO DEVICE. BUT THERE WAS NO ENERGY BEING DELIVERED AND NO POWER OUTPUT. THE STAFF POWERED IT ON AND OFF, UNHOOKED THE CABLE AND RECONNECTED IT BACK ON BUT STILL NO ENERGY. A THIRD REPLACEMENT HEMOPRO DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PATIENT COMPLICATIONS. THIS REPORT IS FOR THE SECOND DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VASOVIEW HEMOPRO ENDOSCOPIC VESSEL HARVESTING SYSTEM GEI GUIDANT CARDIAC SURGERY VH-3000 8062471

    Patients

    Seq Age Sex Outcome Treatment
    1 NA