BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRAPULSE ENCORE

    MDR report key: 6724116 · Received July 19, 2017

    Report

    Report Number
    3004135191-2017-00092
    Event Type
    Malfunction
    Date Received
    July 19, 2017
    Date of Event
    June 19, 2017
    Report Date
    July 19, 2017
    Manufacturer
    LUMENIS, LTD.
    Product Code
    GEX
    PMA / PMN Number
    K022060
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    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: "DID NOT WITNESS ANY ISSUES DURING TESTING THROUGH OVER 500 SHOTS WITH THE OLD FOOTSWITCH, AND OVER 500 SHOTS WITH A NEW FOOTSWITCH." 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. 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 ENCORE LASER, THE DEVICE OPERATOR REPORTED THAT THE LASER DEPLOYED ENERGY WITHOUT THE FOOTSWITCH BEING PRESSED. IT WAS FURTHER REPORTED THAT NO INJURY TO THE PATIENT OR TREATING STAFF MEMBERS HAD OCCURRED. THE FOOTSWITCH WAS SHIPPED TO THE MANUFACTURING FACILITY FOR FURTHER ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    507170 ULTRAPULSE ENCORE CO2 SURGICAL DEVICE GEX LUMENIS, LTD. ULTRAPULSE ENCORE

    Patients

    Seq Age Sex Outcome Treatment
    1