BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 1840265 · Received September 16, 2010

    Report

    Report Number
    1840265
    Event Type
    Malfunction
    Date Received
    September 16, 2010
    Date of Event
    August 25, 2010
    Report Date
    September 16, 2010
    Manufacturer
    MAQUET
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT, US

    Narratives

    Description of Event or Problem · 1

    THE PROVIDER HAD FINISHED WITH ALL THE BLUNT DISSECTING WITH THE CLEAR CONE DEVICE WITH PUTTING 25CC OF AIR IN THE BALLOON AT A TIME. THEN THEY STARTED DIVIDING THE BRANCHES WITH THE SECOND DEVICE. THEY HAD FINISHED WITH THE UPPER LEG BRANCHES AND WERE ABOUT HALF WAY THROUGH WITH THE LOWER LEG. THE BALLOON ON THE DEVICE POPPED, ONCE AGAIN WITH ONLY 25CC OF AIR IN. A SECOND KIT WAS OPENED TO FINISH THE LAST PART BECAUSE WE HAD LOST THE TUNNEL COMPLETELY AND COULD NOT CONTINUE WITHOUT THE TUNNEL.====================== MANUFACTURER RESPONSE FOR VASOVIEW HEMOPRO ENDOSCOPIC VESSEL HARVESTING SYSTEM PER SITE REPORTER======================MANUFACTURER PROVIDED RGA AND PACKAGING FOR PRODUCT RETURN EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * SYSTEM, VESSEL HARVESTING, ENDOSCOPIC GEI MAQUET * 25013207

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR