BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXCEL CONSOLE

    MDR report key: 1820076 · Received August 24, 2010

    Report

    Report Number
    3006697299-2010-00005
    Event Type
    Malfunction
    Date Received
    August 24, 2010
    Date of Event
    July 30, 2010
    Report Date
    August 24, 2010
    Manufacturer
    INTERGRA IRELAND LTD
    Product Code
    LFL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    THE CUSA EXCEL LOANER UNIT STARTED TO SMOKE INTERNALLY DURING PRIMING STAGE OF SET UP. THE UNIT WAS TESTED OUTSIDE THE OPERATING ROOM BEFORE USING ON THE PATIENT. NO ONE WAS INJURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXCEL CONSOLE ULTRASONIC SURGICAL PRODUCTS LFL INTERGRA IRELAND LTD

    Patients

    Seq Age Sex Outcome Treatment
    1