BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRALASE FS LASER

    MDR report key: 423463 · Received October 18, 2002

    Report

    Report Number
    2032002-2002-00002
    Event Type
    Malfunction
    Date Received
    October 18, 2002
    Date of Event
    September 19, 2002
    Report Date
    September 19, 2002
    Manufacturer
    INTRALASE CORP.
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING PREPARATION FOR LASIK SURGERY 02, THE SURGEON EXPERIENCED A DEVICE MALFUNCTION WITH THE INTRALASE FS LASER. THERE WAS NO PT INJURY REPORTED. DURING PREPARATION, THE PT WAS POSITIONED ON THE BED AND SUCTION WAS APPLIED. THE SURGEON WAS ADJUSTING THE BED POSITION AND GANTRY POSITION OF THE LASER, AND WAS PREPARING TO DOCK THE EYE. THE LASER GANTRY GENERATED A CRACKING/GRINDING NOISE; THE LASER STOPPED MOVING THEN MOVED IN THE Y-DIRECTION APPROXIMATELY ONE INCH. BECAUSE THE CONE HAD NOT BEEN DOCKED ON THE PT AT THIS POINT, THE PT WAS COMPLETELY UNAFFECTED BY THE MOVEMENT OF THE GANTRY. THIS EVENT IS BEING REPORTED AS A MALFUNCTION MDR BECAUSE UNEXPECTED MOVEMENT OF THE GANTRY IN THE X, Y, OR Z (DOWN) DIRECTIONS HAS THE POTENTIAL TO CAUSE INJURY TO THE EYE.

    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 NO INFO