BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUIDANT VASO VIEW 7 ENDOSCOPIC VESSEL HARVESTING SYSTEM

    MDR report key: 1063674 · Received June 20, 2008

    Report

    Report Number
    2953148-2008-00624
    Event Type
    Malfunction
    Date Received
    June 20, 2008
    Date of Event
    May 29, 2008
    Report Date
    May 29, 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
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS: NO VISUAL OR FUNCTIONAL NON-CONFORMITIES WERE FOUND. THE COMPLAINT WAS NOT CONFIRMED FOR DEVICE WOULD NOT CAUTERIZE. A LHR REVIEW WAS COMPLETED FOR THE PRODUCT AND THERE WAS NONCONFORMANCE ASSOCIATED WITH THE LOT NUMBER.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING THE ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE DEVICE WOULD NOT CAUTERIZE. A REPLACEMENT UNIT WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PT COMPLICATIONS.

    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 7081672

    Patients

    Seq Age Sex Outcome Treatment
    1 NA