BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO ENDOSCOPIC VESSEL HARVESTING SYSTEM

    MDR report key: 1191878 · Received October 1, 2008

    Report

    Report Number
    2953148-2008-00819
    Event Type
    Malfunction
    Date Received
    October 1, 2008
    Date of Event
    September 11, 2008
    Report Date
    September 11, 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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS: THE INVESTIGATION WAS COMPLETED. DEVICE PASSES THE MECHANICAL, ELECTRICAL AND THE SIMULATED CAUTERY TEST. THE REPORTED COMPLAINT THAT THE "DEVICE WOULD NOT SHUT OFF", COULD NOT BE CONFIRMED. 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 HEMOPRO DEVICE WOULD NOT SHUT OFF AFTER FINISHED BURNING A BRANCH. DEVICE WAS IMMEDIATELY UNPLUGGED FROM THE POWER SUPPLY. THE HOSPITAL USED A SECOND HEMOPRO DEVICE, SUCCESSFULLY COMPLETED THE CASE. NO PT COMPLICATIONS WERE REPORTED BY THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VASOVIEW HEMOPRO ENDOSCOPIC VESSEL HARVESTING SYSTEM GEI GUIDANT CARDIAC SURGERY VH-3000 8072071

    Patients

    Seq Age Sex Outcome Treatment
    1 NA