BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONCERTO

    MDR report key: 2161075 · Received June 16, 2011

    Report

    Report Number
    3003288808-2011-00128
    Event Type
    Malfunction
    Date Received
    June 16, 2011
    Date of Event
    March 16, 2010
    Report Date
    March 16, 2010
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    LZS
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LG
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING THE ONSITE INVESTIGATION, THE SVC TECH UPDATED THE LASER FIRMWARE. ROOT CAUSE WAS IDENTIFIED AS THE NEED FOR UPDATED FIRMWARE. (B)(4). THIS REPORT WAS MAILED TO FDA ON: (B)(4) 2011. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTS, THE LASER NO LONGER REACTS; AFTER SENDING THE TREATMENT DATA IT IS NO LONGER POSSIBLE TO EXECUTE A FUNCTION. NO PT HARM REPORTED AND NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONCERTO OPHTHALMIC EXCIMER LASER SYSTEM LZS WAVELIGHT GMBH 6065990602 NA

    Patients

    Seq Age Sex Outcome Treatment
    1