BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPROBE

    MDR report key: 882056 · Received June 15, 2007

    Report

    Report Number
    882056
    Event Type
    Malfunction
    Date Received
    June 15, 2007
    Date of Event
    June 5, 2007
    Report Date
    June 15, 2007
    Manufacturer
    IRIDEX CORPORATION
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US

    Narratives

    Description of Event or Problem · 1

    WHEN THE PROBE WAS CONNECTED TO THE LASER MACHINE AN AIMING BEAM WAS NOTED FROM MIDDLE OF THE PROBE. THE LASER WAS NOT TAKEN FROM STANDBY AND THE PROBE WAS IMMEDIATELY REMOVED FROM THE STERILE FIELD. THE PROBE WAS NEVER USED ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPROBE LASER ENDOPROBE GEX IRIDEX CORPORATION * 012216

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR