BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRAPULSE TOTALFX

    MDR report key: 6724118 · Received July 19, 2017

    Report

    Report Number
    3004135191-2017-00094
    Event Type
    Malfunction
    Date Received
    July 19, 2017
    Report Date
    July 19, 2017
    Manufacturer
    LUMENIS, LTD.
    Product Code
    GEX
    PMA / PMN Number
    K030147
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    LUMENIS INVESTIGATED THE REPORTED EVENT BY CONTACTING THE USER FACILITY DIRECTLY (3X) BY PHONE TO OBTAIN RELEVANT INFORMATION, WHICH HAS NOT BEEN PROVIDED. AN EXAMINATION OF THE SUBJECT DEVICE BY A LUMENIS TECHNICAL EXPERT NOTED THAT THE REPORTED ISSUE COULD NOT BE REPRODUCED DESPITE MULTIPLE ATTEMPTS. THE TECHNICAL EXPERT STATED: "POWERED UNIT ON AND FIRED THROUGH 100+ SHOTS AT VARIOUS SETTINGS WITHOUT RECURRENCE OF ERROR." THE EXPERT VERIFIED THAT THE SUBJECT DEVICE ENERGY OUTPUT WAS WITHIN LUMENIS SPECIFICATIONS AND PASSED ALL OPERATIONAL AND SAFETY TESTS. THE LASER DEVICE WAS VERIFIED TO BE SAFE TO USE AND WAS RETURNED TO SERVICE AT THE USER FACILITY. ADDITIONALLY, CUSTOMER WAS ADVISED TO USE EMERGENCY SWITCH IN CASE OF UNINTENDED FIRING. ALTHOUGH LUMENIS WAS NOT ABLE TO CONFIRM THE ALLEGED MALFUNCTION AT TIME OF SERVICE, LUMENIS IS REPORTING THIS EVENT IN AN ABUNDANCE OF CAUTION. LUMENIS IS STILL INVESTIGATING THE REPORTED ISSUE AND EXPECTING THE SUSPECTED FOOT SWITCH TO BE RETURNED FOR FURTHER EVALUATION. LUMENIS WILL FILE A FOLLOW-UP MDR IF OR WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    A USER FACILITY REPORTED THAT DURING A PROCEDURE WITH A LUMENIS ULTRAPULSE TOTAL FX LASER, ACTIVE FX HANDPIECE, THE DEVICE OPERATOR REPORTED THAT THE LASER CONTINUED TO DEPLOY ENERGY AFTER THE PHYSICIAN REMOVED FOOT FROM THE FOOTSWITCH. IT WAS FURTHER REPORTED THAT THE LASER BEAM WAS REMOVED FROM THE PATIENT AND LEFT A BURN MARK ON THE WALL. ADDITIONALLY, THE USER FACILITY REPORTED THAT NO INJURY TO THE PATIENT HAD OCCURRED. THE FOOTSWITCH WAS SHIPPED TO THE MANUFACTURING FACILITY FOR FURTHER ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    507193 ULTRAPULSE TOTALFX CO2 SURGICAL DEVICE GEX LUMENIS, LTD. ULTRAPULSE TOTAL FX

    Patients

    Seq Age Sex Outcome Treatment
    1