BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LADARVISION 4000 LASER

    MDR report key: 1191966 · Received October 1, 2008

    Report

    Report Number
    3003288808-2008-00014
    Event Type
    Malfunction
    Date Received
    October 1, 2008
    Date of Event
    September 1, 2008
    Report Date
    September 1, 2008
    Manufacturer
    ALCON-ORLANDO TECHNOLOGY CENTER
    Product Code
    LZS
    PMA / PMN Number
    P970043
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING THE ON SITE INVESTIGATION, THE TERRITORY MANAGER (TM) PERFORMED SAME DAY SURGERY TESTS AND FOUR TEST SURGERIES AND WAS UNABLE TO DUPLICATE THE LASER NOT FIRING ISSUE. THE TM REPLACED THE FOOTSWITCH AS A PREVENTATIVE MEASURE AND PERFORMED A SYSTEM VERIFICATION TO SPEC. THE SURGERY DATABASE WAS REVIEWED BY QUALITY ENGINEERING AND THE EVENT WAS VERIFIED AS REPORTED. RETURNED PART EVAL IS PENDING. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADD'L REPORTABLE INFO BECOMES AVAILABLE. (B) (4). (B) (4). (B) (4).

    Description of Event or Problem · 1

    A SYSTEMS OPERATOR REPORTS THE LASER STOPPED FIRING DURING A PROCEDURE. THE PROCEDURE WAS COMPLETED AND THE SURGEON STATED, THE PT WAS NOT HARMED OR INJURED BY THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LADARVISION 4000 LASER EXCIMER LASER SYSTEM LZS ALCON-ORLANDO TECHNOLOGY CENTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA