BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTILASER SYSTEM

    MDR report key: 5536269 · Received March 30, 2016

    Report

    Report Number
    2428235-2016-00004
    Event Type
    Malfunction
    Date Received
    March 30, 2016
    Date of Event
    February 29, 2016
    Report Date
    March 30, 2016
    Manufacturer
    CYNOSURE, INC. DBA ELLMAN
    Product Code
    GEX
    PMA / PMN Number
    K123777
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TECHNICIAN FOUND THE LASER DEVICE INOPERABLE AND DETERMINED ITS FOOTSWITCH HAD MALFUNCTIONED, CAUSING THE IMMEDIATE RELEASE OF ENERGY. THIS REQUIRED THE TECHNICIAN TO REPLACE THE FOOTSWITCH AND PERFORM ADDITIONAL SYSTEM MAINTENANCE. THIS IS AN EXAMPLE OF AN ACCIDENTAL RADIATION OCCURRENCE (ARO) AND WHILE THERE WAS NO PATIENT INVOLVED, THERE IS A POTENTIAL FOR INJURY.

    Description of Event or Problem · 1

    LASER DEVICE EMITTED ENERGY UPON SYSTEM STARTUP, WHICH COULD LEAD TO POTENTIAL INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191047 MULTILASER SYSTEM MEDLEY LASER SYSTEM GEX CYNOSURE, INC. DBA ELLMAN SSMEDLC110 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1