BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLEGRETTO WAVE EYE-Q

    MDR report key: 2160965 · Received June 16, 2011

    Report

    Report Number
    3003288808-2011-00184
    Event Type
    Malfunction
    Date Received
    June 16, 2011
    Date of Event
    September 10, 2009
    Report Date
    September 10, 2009
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    LZS
    PMA / PMN Number
    P030008/P02
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DURING THE ONSITE INVESTIGATION, THE SERVICE TECHNICIAN REPLACED THE LASER HEAD. ROOT CAUSE WAS IDENTIFIED AS A FAULTY LASER HEAD. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTS SMELL OF SMOKE FROM LASER AND SYSTEM MESSAGE DURING TREATMENTS INDICATING COMMUNICATION-LASER HEAD. NO PATIENT HARM WAS REPORTED AND NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALLEGRETTO WAVE EYE-Q OPHTHALMIC EXCIMER LASER SYSTEM LZS WAVELIGHT GMBH 8065990631 NA

    Patients

    Seq Age Sex Outcome Treatment
    1