BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW 7XB ENDOSCOPIC VESSEL HARVESTING SYSTEM

    MDR report key: 1231021 · Received October 28, 2008

    Report

    Report Number
    2953148-2008-00870
    Event Type
    Malfunction
    Date Received
    October 28, 2008
    Date of Event
    October 9, 2008
    Report Date
    October 9, 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
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER THE PROCEDURE, THE HOSPITAL DISCARDED THE PRODUCT. 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 BISECTOR DID NOT CAUTERIZE. A REPLACEMENT UNIT WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VASOVIEW 7XB ENDOSCOPIC VESSEL HARVESTING SYSTEM GCJ GUIDANT CARDIAC SURGERY VH-3200 8082671

    Patients

    Seq Age Sex Outcome Treatment
    1 NA