BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO ENDOSCOPIC VESSEL HARVESTING SYSTEM

    MDR report key: 1181403 · Received September 24, 2008

    Report

    Report Number
    2953148-2008-00802
    Event Type
    Malfunction
    Date Received
    September 24, 2008
    Date of Event
    September 5, 2008
    Report Date
    September 5, 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
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS: THE VISUAL INSPECTION SHOWED THAT THE TRI-HEATER WIRE ASSEMBLIES ON THE HOT JAW BOOT WERE CLEAN AND APPEARED TO BE UNDAMAGED. THE COLD JAW BOOTS SHOWED LITTLE SIGN OF THERMAL DAMAGE ON THE SERRATED SURFACE OF THE JAWS. THE HEMOPRO DEVICE AND CABLE USED DURING THE TRAINING WERE CONNECTED TO A REFERENCE POWER SUPPLY. 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. IT WAS CONCLUDED THAT THE DEVICE AND THE CABLE WERE FUNCTIONING CORRECTLY. THE REPORTED FAILURE COULD NOT BE 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

    IT WAS REPORTED THAT DURING A CADAVER LAB ENDOSCOPIC VEIN HARVESTING TRAINING BY A MAQUET SALES REPRESENTATIVE, THE HEMOPRO TISSUE WELDER WOULD NOT DISENGAGE. THE DEVICE TURNED RED, BECAME HOT AND STARTED SMOKING. THE TOGGLE SWITCH WAS DEPRESSED BUT IT WOULD NOT STOP HEATING. THE DEVICE WAS REMOVED AND THE TOGGLE SWITCH WAS DEPRESSED BUT DEVICE STILL WOULD NOT SHUT OFF. A REPLACEMENT DEVICE WS CONNECTED USING THE SAME CABLE WITHOUT ANY FURTHER ISSUES. THE TREATING WAS COMPLETED. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VASOVIEW HEMOPRO ENDOSCOPIC VESSEL HARVESTING SYSTEM GEI GUIDANT CARDIAC SURGERY VH-3000 8043071

    Patients

    Seq Age Sex Outcome Treatment
    1 NI