BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLEGRETTO WAVE

    MDR report key: 1834425 · Received September 10, 2010

    Report

    Report Number
    3003288808-2010-00425
    Event Type
    Malfunction
    Date Received
    September 10, 2010
    Date of Event
    August 12, 2010
    Report Date
    August 12, 2010
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    LZS
    PMA / PMN Number
    P030008
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    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 REPORTABLE INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    ADVERSE EVENT(S): "NONE REPORTED" (NO INFO). PRODUCT PROBLEM(S): "NITROGEN LINE BURST" (BURST). A TECHNICIAN REPORTS HEARING A LEAK FROM THE NITROGEN LINE. THE PT WAS IN THE PROCESS OF HAVING THE FLAP MADE ON THE LEFT EYE WHEN THE NITROGEN LINE MADE A LOUD POPPING SOUND AND BURST. THE VALVE ON THE NITROGEN TANK WAS IMMEDIATELY CLOSED, THE LASER WAS TURNED OFF AND ALL PERSONNEL, INCLUDING THE PT, WERE REMOVED FROM THE LASER SUITE. THE TERRITORY MANAGER (TM) WAS CALLED TO COME AND REPAIR THE BROKEN LINE. A BANDAGE CONTACT LENS WAS PLACED ON THE PT'S LEFT EYE FOR APPROXIMATELY 3 HOURS WHILE THE LASER WAS REPAIRED. FOLLOWING THE REPAIR, THE PT'S TREATMENT WAS COMPLETED ALONG WITH THE OTHER 10 PTS SCHEDULED FOR SURGERY THAT DAY. ADDITIONAL INFO HAS BEEN REQUESTED.

    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