BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTENDEVAC

    MDR report key: 856625 · Received May 3, 2007

    Report

    Report Number
    856625
    Event Type
    Malfunction
    Date Received
    May 3, 2007
    Date of Event
    April 24, 2007
    Report Date
    May 3, 2007
    Manufacturer
    DEROYAL INDUSTRIES
    Product Code
    FCZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    ESU WAS BEING USED BY SURGEON AND SHE WAS NOT ABLE TO TURN IT OFF AND HAD TO UNPLUG THE UNIT AND USE ANOTHER DEVICE. THERE WAS NO PATIENT INJURY NOR DELAY IN SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXTENDEVAC ESU, SMOKE EVACUATION SUCTION FCZ DEROYAL INDUSTRIES * 11714033

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR