BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUMENIS ONE

    MDR report key: 2909833 · Received January 11, 2013

    Report

    Report Number
    3004135191-2013-00004
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    December 13, 2012
    Report Date
    January 9, 2013
    Manufacturer
    LUMENIS, LTD.
    Product Code
    GEX
    PMA / PMN Number
    K050639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY DECLINED SERVICE OF THE SUBJECT DEVICE BY LUMENIS TECHNICAL REPRESENTATIVE. A REVIEW OF THE SERVICE RECORDS FOR THE SUBJECT DEVICE CONCLUDED THAT NO SERVICE HAD BEEN PERFORMED BY LUMENIS ON THE SUBJECT DEVICE SINCE JANUARY 2011. LUMENIS CANNOT RULE OUT THAT SERVICE BY UNAUTHORIZED THIRD PARTY SERVICE PROVIDERS MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. TO THE BEST OF LUMENIS' KNOWLEDGE, THE SUBJECT DEVICE REMAINS IN USE AT THE USER FACILITY. ABSENT SUBJECT DEVICE EXAMINATION, LUMENIS CANNOT DETERMINE A ROOT CAUSE FOR THE EVENTS REPORTED. LUMENIS IS REPORTING THIS COMPLAINT SINCE IT IS SIMILAR TO AN EVENT IN WHICH THE COOLING SYSTEM LEAK RESULTED IN COMBUSTION OF THE HIGH VOLTAGE POWER SUPPLY.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT A COOLING SYSTEM LEAK OCCURRED IN A LUMENIS ONE LASER. NO REPORT OF RELATED INJURY WAS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18098 LUMENIS ONE INTENSE PULSE LIGHT DELIVERY DEVICE GEX LUMENIS, LTD. LUMENIS ONE

    Patients

    Seq Age Sex Outcome Treatment
    1 Other