BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VASOVIEW HEMOPRO ENDOSCOPIC VESSEL HARVESTING SYSTEM

    MDR report key: 1153070 · Received September 8, 2008

    Report

    Report Number
    2953148-2008-00779
    Event Type
    Injury
    Date Received
    September 8, 2008
    Date of Event
    August 19, 2008
    Report Date
    August 19, 2008
    Manufacturer
    GUIDANT CARDIAC SURGERY
    Product Code
    GEI
    PMA / PMN Number
    K052274
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS: THE VISUAL INSPECTION SHOWED THAT THE COLD JAW BOOT INSULATION WAS COMPLETELY DETACHED FROM TISSUE WELDER'S COLD JAWS. NO OTHER MECHANICAL OR ELECTRICAL PERFORMANCE NON-CONFORMITIES WERE FOUND. THERE REPORTED FAILURE WAS CONFIRMED. 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 HALF WAY THROUGH THE ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE SURGEON DID NOT HAVE A GOOD CUT WHILE CAUTERIZING THE VEIN. IT WAS DISCOVERED THAT THE SILICON JAW BOOT CAME OFF FROM THE DEVICE. THE JAW BOOT WAS RETRIEVED THROUGH THE ORIGINAL INCISION. THERE WAS NO ADDITIONAL MEDICAL OR SURGICAL INTERVENTION REQUIRED. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PATIENT COMPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VASOVIEW HEMOPRO ENDOSCOPIC VESSEL HARVESTING SYSTEM GEI GUIDANT CARDIAC SURGERY VH-3000 8062071

    Patients

    Seq Age Sex Outcome Treatment
    1 NA