BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW 7XB ENDOSCOPIC VESSEL HARVESTING SYSTEM

    MDR report key: 1191877 · Received October 1, 2008

    Report

    Report Number
    2953148-2008-00820
    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
    GCJ
    PMA / PMN Number
    K030512
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION WAS COMPLETED AND THE DEVICE PASSED THE ELECTRICAL SPECIFICATIONS AND THE SIMULATED CAUTERY TEST. THE REPORTED COMPLAINT IS NOT 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 BISECTOR WOULD NOT CAUTERIZE. TROUBLESHOOTING CONSISTED OF CHANGING THE: CORD, BOVIE AND FOOT PEDAL WITH SIMILAR RESULTS. A REPLACEMENT DEVICE WAS USED AND INITIALLY THAT DID NOT CAUTERIZE, BUT EVENTUALLY, IT DID CAUTERIZE AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO PT COMPLICATIONS WERE REPORTED BY THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VASOVIEW 7XB ENDOSCOPIC VESSEL HARVESTING SYSTEM GCJ GUIDANT CARDIAC SURGERY VH-3200 8071072

    Patients

    Seq Age Sex Outcome Treatment
    1 NA