BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRALASE FS LASER

    MDR report key: 527960 · Received February 26, 2004

    Report

    Report Number
    2032002-2004-00001
    Event Type
    Malfunction
    Date Received
    February 26, 2004
    Date of Event
    January 30, 2004
    Report Date
    January 30, 2004
    Manufacturer
    INTRALASE CORP.
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE SURGEON WAS ATTEMPTING TO DOCK THE PATIENT'S EYE IN PREPARATION FOR LASIK SURGERY USING THE INTRALASE FS LASER. WHEN THE SURGEON ACTUATED THE JOYSTICK DOWN TO DOCK ON THE EYE THE MOTOR STARTED MAKING A GRINDING NOISE. THE JOYSTICK WAS RELEASED AND THE GANTRY STOPPED MOVING. THE PATIENT BED WAS ROTATED AND THE PATIENT WAS MOVED FROM UNDER THE GANTRY. THE GANTRY DID NOT CONTACT THE PATIENT AND THERE WAS NO RESULTING INJURY. AFTER THE PATIENT WAS OUT OF THE WAY, THE SURGEON ATTEMPTED TO MOVE THE JOYSTICK IN THE UPWARD DIRECTION, HOWEVER THE GANTRY MOVED IN THE DOWNWARD DIRECTION. THE CUSTOMER ALSO REPORTED THAT THIS SAME SCENARIO OCCURRED APPROXIMATELY ONE MONTH EARLIER WITH NO RESULTING INJURY, HOWEVER THEY DID NOT CONTACT INTRALENSE TO REPORT THE INCIDENT. THIS EVENT IS BEING REPORTED AS A DEVICE MALFUNCTION MDR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTRALASE FS LASER LASER KERATOME GEX INTRALASE CORP. 20002 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN