BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLEGRETTO WAVE EYE-Q

    MDR report key: 1823620 · Received August 27, 2010

    Report

    Report Number
    3003288808-2010-00415
    Event Type
    Malfunction
    Date Received
    August 27, 2010
    Date of Event
    July 30, 2010
    Report Date
    July 30, 2010
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    LZS
    PMA / PMN Number
    P030008
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    UNKNOWN

    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 REPORTABLE INFO BECOMES AVAILABLE. (B)(4)

    Description of Event or Problem · 1

    ADVERSE EVENT(S): "NO HARM TO PT" (NO CONSEQUENCES OR IMPACT TO PT). PRODUCT PROBLEM(S): "MACHINE NEEDED RESETTING" (RESET ISSUE). A CUSTOMER REPORTED THAT DURING SURGERY, THE MACHINE NEEDED RESETTING. DURING FOLLOW-UP CONVERSATIONS WITH THE CUSTOMER, IT WAS DETERMINED THERE WAS NO PROBLEM WITH THE ACTUAL SYSTEM, THE LAPTOP HAS A COUNTER WHICH TIMES OUT AFTER A CERTAIN AMOUNT OF TIME WHICH REQUIRES A TREATMENT CODE TO BE ENTERED. THE FILED ENGINEER WAS CONTACTED AND WAS ABLE TO PROVIDE THE CUSTOMER WITH THE CODE. THE SURGERY WAS COMPLETED. THE CUSTOMER INDICATED THE PT'S FLAP WAS CUT ON THE RIGHT EYE, BUT NOT LIFTED. THE DELAY WAS OVER 3 HOURS, BUT THE CUSTOMER STATED THERE WAS NO AFFECT ON THE PT'S OUTCOME. ADDITIONAL INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALLEGRETTO WAVE EYE-Q OPHTHALMIC EXCIMER LASER SYSTEM LZS WAVELIGHT GMBH 8065990601 NA

    Patients

    Seq Age Sex Outcome Treatment
    1