BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUIDANT VASO VIEW 7 ENDOSCOPIC VESSEL HARVESTING SYSTEM

    MDR report key: 1022247 · Received March 26, 2008

    Report

    Report Number
    2953148-2008-00310
    Event Type
    Malfunction
    Date Received
    March 26, 2008
    Date of Event
    February 29, 2008
    Report Date
    March 4, 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
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS: INVESTIGATION WAS COMPLETED AND THE DEVICE PASSED THE ELECTRICAL SPECIFICATIONS AND THE SIMULATED CAUTERY TEST. THE COMPLAINT IS NOT CONFIRMED FOR THE BISECTOR WOULD NOT CAUTERIZE SINCE THERE WERE NO NON-CONFORMANCE DISCOVERED DURING THE INVESTIGATION.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE BISECTOR DID NOT FUNCTION. IT WOULD NOT CAUTERIZE. THE BOVIE CORD WAS REPLACED AND CONNECTED WITH SIMILAR RESULTS. THE HOSPITAL USED A SECOND BISECTOR, SUCCESSFULLY COMPLETED THE CASE. NO PT COMPLICATIONS WERE REPORTED BY THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GUIDANT VASO VIEW 7 ENDOSCOPIC VESSEL HARVESTING SYSTEM GCJ GUIDANT CARDIAC SURGERY VH-3200 7102271

    Patients

    Seq Age Sex Outcome Treatment
    1 NA