BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STONELIGHT LASER SYSTEM

    MDR report key: 3111597 · Received May 6, 2013

    Report

    Report Number
    2937094-2013-00548
    Event Type
    Malfunction
    Date Received
    May 6, 2013
    Date of Event
    January 11, 2013
    Report Date
    January 11, 2013
    Manufacturer
    AMERICAN MEDICAL SYSTEMS
    Product Code
    GEX
    PMA / PMN Number
    K994273
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AMS SERVICE ENGINEER WAS DISPATCHED TO THE USERS FACILITY. THIS CONSOLE WAS EVALUATED, AND REPAIRED IN THE FIELD. THE LASER WAS RELEASED TO THE CUSTOMER FOR USE ON (B)(6) 2013.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE IT WAS NOTED THAT THE LASER WAS RUNNING HOT, AND WHEN THE LASER WAS RESTARTED THE LASER WOULD NOT TURN ON. ADDITIONAL INFORMATION IS NOT AVAILABLE. NO INJURY TO THE PATIENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196065 STONELIGHT LASER SYSTEM POWERED SURGICAL LASER INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS 0010-9260

    Patients

    Seq Age Sex Outcome Treatment
    1