BEUDAMED
    FDA Adverse Event Other Summary report: N

    GUIDANT

    MDR report key: 910384 · Received September 10, 2007

    Report

    Report Number
    MW5003702
    Event Type
    Other
    Date Received
    September 10, 2007
    Date of Event
    August 1, 2007
    Report Date
    August 29, 2007
    Manufacturer
    GUIDANT CORP
    Product Code
    GCJ
    Report Source
    Voluntary report
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    TIP OF HEMOPRO GOT TOO HOT. TIP TURNED BRIGHT RED. REP. NOTIFIED BIOMED CALLED TO INSPECT GENERATOR USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GUIDANT VASOVIEW HEMOPRO-ENDOSCOPIC VESSEL HARVESTING SYSTEM GCJ GUIDANT CORP REF VH-3000 7062771
    2 GUIDANT VASOVIEW HEMO PRO-ENDOSCOPIC VESSEL HARVESTING SYSTEM GCJ GUIDANT CORPORATION REF VH - 3000 7062771
    3 GUIDANT VASOVIEW HEMO PRO-ENDOSCOPIC VESSEL HARVESTING SYSTEM GCJ GUIDAN CORPORATION REF VH - 3000 7062771
    4 GUIDANT VASOVIEW HEMO PRO-ENDOSCOPIC VESSEL HARVESTING SYSTEM GCJ GUIDAN CORPORATION REF VH - 3000 7062771

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other