BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUIDANT VASOVIEW 7 ENDOSCOPIC VESSEL HARVESTING SYSTEM

    MDR report key: 1023490 · Received April 2, 2008

    Report

    Report Number
    2953148-2008-00318
    Event Type
    Malfunction
    Date Received
    April 2, 2008
    Date of Event
    March 19, 2008
    Report Date
    March 19, 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
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER THE PROCEDURE, THE HOSPITAL DISCARDED THE PRODUCT. SINCE THE PRODUCT WAS NOT RETURNED TO CARDIAC SURGERY FOR EVALUATION, IT WILL BE DIFFICULT TO CONFIRM THE REPORTED PROBLEM. A LHR REVIEW CANNOT BE PERFORMED BECAUSE THE LOT NUMBER WAS NOT PROVIDED BY THE HOSPITAL.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING THE ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE BISECTOR WAS INTERMITTENTLY SMOKING AND 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 VASOVIEW 7 ENDOSCOPIC VESSEL HARVESTING SYSTEM GCJ GUIDANT CARDIAC SURGERY VH-3200 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA