BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WAVELIGHT FS200 FEMTOSECOND LASER

    MDR report key: 2201129 · Received July 29, 2011

    Report

    Report Number
    3003288808-2011-00238
    Event Type
    Malfunction
    Date Received
    July 29, 2011
    Date of Event
    June 29, 2011
    Report Date
    June 30, 2011
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    LZS
    PMA / PMN Number
    K101006
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTS THAT THE DISTANCE DIODES WERE NOT ACTIVATED WHEN ADJUSTING THE PT UNDER THE SYSTEM. AFTER SYSTEM REBOOT, A SYSTEM ERROR MESSAGE WAS RECEIVED AFTER CALIBRATION. THE WAVE CARD WAS NO LONGER ACCEPTED BY THE LASER. NO PT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WAVELIGHT FS200 FEMTOSECOND LASER OPHTHALMIC FEMTOSECOND LASER LZS WAVELIGHT GMBH FS200 NA

    Patients

    Seq Age Sex Outcome Treatment
    1