BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLEGRETTO WAVE

    MDR report key: 2160982 · Received June 16, 2011

    Report

    Report Number
    3003288808-2011-00120
    Event Type
    Malfunction
    Date Received
    June 16, 2011
    Report Date
    March 31, 2008
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    LZS
    PMA / PMN Number
    P030008/P0
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SERVICE TECHNICIAN TESTED THE SYSTEM AND FOUND NO FAILURES. THERE WAS NO ROOT CAUSE, AS THE LASER WAS OPERATING WITHIN SPECIFICATIONS. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTS THE LASER EMITS A CONSIDERABLE DECENTERED RADIATION DURING TREATMENT. THIS WAS DETECTED BY THE PHYSICIAN VIA MICROSCOPE. NO PT HARM WAS REPORTED AND NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALLEGRETTO WAVE OPHTHALMIC EXCIMER LASER SYSTEM LZS WAVELIGHT GMBH 8065990600 NA

    Patients

    Seq Age Sex Outcome Treatment
    1