BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO ENDOSCOPIC VESSEL HARVESTING SYSTEM

    MDR report key: 1232752 · Received November 14, 2008

    Report

    Report Number
    2953148-2008-00915
    Event Type
    Malfunction
    Date Received
    November 14, 2008
    Date of Event
    October 30, 2008
    Report Date
    October 31, 2008
    Manufacturer
    GUIDANT CARDIAC SURGERY
    Product Code
    GEI
    PMA / PMN Number
    K052274
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    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

    IT WAS REPORTED THAT DURING PREPARATION FOR AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, PRIOR TO INSERTING IN THE PATIENT'S LEG, THE D.C. EXTENSION CABLE WAS CONNECTED TO THE HEMOPRO DEVICE AND IMMEDIATELY ACTIVATED THE ENERGY TO THE TISSUE WELDER'S JAWS WITHOUT THE TOGGLE SWITCH BEING IN THE "ON" POSITION. 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 HEMOPRO ENDOSCOPIC VESSEL HARVESTING SYSTEM GEI GUIDANT CARDIAC SURGERY VH-3000 8082871

    Patients

    Seq Age Sex Outcome Treatment
    1 NA