BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LASER MICROMANIPULATOR JOYSTICK

    MDR report key: 5034312 · Received August 27, 2015

    Report

    Report Number
    5034312
    Event Type
    Malfunction
    Date Received
    August 27, 2015
    Date of Event
    July 9, 2015
    Report Date
    August 14, 2015
    Manufacturer
    LUMENIS LTD
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INTRAOPERATIVELY AT 1022, THE C02 LUMENIS LASER MICRO MANIPULATOR JOYSTICK BROKE AND NEEDED TO BE HELD DURING LASERING. SURGERY WAS PERFORMED BUT LASER NEEDED TO BE TURNED OFF AND ON SEVERAL TIMES DURING THE CASE. LUMENIS ASSIGNED CASE #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    567574 LASER MICROMANIPULATOR JOYSTICK POWERED LASER SURGICAL INSTRUMENT GEX LUMENIS LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR