BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUMENIS ONE

    MDR report key: 6979478 · Received October 26, 2017

    Report

    Report Number
    3004135191-2017-00197
    Event Type
    Malfunction
    Date Received
    October 26, 2017
    Report Date
    October 26, 2017
    Manufacturer
    LUMENIS, LTD.
    Product Code
    GEX
    PMA / PMN Number
    K060448
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    SERVICE AND TESTING PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    A FOREIGN USER FACILITY REPORTED THAT A COOLING SYSTEM LEAK OCCURRED IN A LUMENIS ONE LASER. NO REPORT OF RELATED INJURY WAS RECEIVED. LUMENIS INVESTIGATED THE REPORTED COMPLAINT. A LUMENIS TECHNICAL EXPERT COMPLETED AN EXAMINATION OF THE SUBJECT DEVICE IDENTIFYING A CRACK IN A COOLANT TUBE FITTING TO BE THE CAUSE OF THE EVENT REPORT. ADDITIONAL INFO OCT 26 2017: AS PART OF REMEDIAL ACTIVITY LUMENIS PERFORMED RETRO REVIEW OF ALL SAFETY COMPLAINTS INITIATED BETWEEN JAN 01 2015 UNTIL JUN 02 2017. 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

    A FOREIGN 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
    760545 LUMENIS ONE INTENSE PULSE LIGHT DELIVERY DEVICE GEX LUMENIS, LTD. LUMENIS ONE

    Patients

    Seq Age Sex Outcome Treatment
    1 Other