BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGHTSHEER XC

    MDR report key: 14235792 · Received April 28, 2022

    Report

    Report Number
    1720381-2022-00001
    Event Type
    Injury
    Date Received
    April 28, 2022
    Date of Event
    August 19, 2019
    Report Date
    April 26, 2022
    Manufacturer
    LUMENIS LTD
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE INITIAL REPORT WAS SUBMITTED UNDER EXEMPTION # E2017002 ONLY UNDER THE MFR REGISTRATION NUMBER OF LUMENIS LTD (THE MANUFACTURER), (B)(4). THIS EXEMPTION WAS REVOKED EFFECTIVE JUNE 30, 2019. THEREFORE, THE CURRENT SUPPLEMENTAL REPORT IS INTENDED TO COVER THE REPORTING REQUIREMENT OF THE SAME REPORTABLE EVENT FOR LUMENIS INC., THE IMPORTER, UNDER REGISTRATION NO. (B)(4). LUMENIS INVESTIGATED THE REPORTED EVENT BY CONTACTING THE USER FACILITY DIRECTLY. THREE ATTEMPTS HAVE BEEN MADE BY PHONE TO OBTAIN; PATIENT TREATMENT SETTINGS, PATIENT INFORMATION, PATIENT PHOTOS, WHICH WERE PROVIDED, EXCEPT FOR PATIENT'S PHOTOS. A REVIEW OF SUBJECT DEVICE SERVICE RECORDS REVEALED THAT THE DEVICE WAS INSTALLED AT THE FACILITY ON DEC 2005, AND HAS BEEN SERVICED BY LUMENIS ON DEC 2018. THE FACILITY WAS OFFERED TO EVALUATE THE DEVICE AFTER THE ADVERSE EVENT BUT REFUSED. A LUMENIS HEALTHCARE PROFESSIONAL AND CLINICAL TRAINER CONCLUDED "I RECEIVED A CALL FROM DR. (B)(6) ON (B)(6) 2019 . HE ASKED IF I'VE EVER HEARD OF A PATIENT HAVING A DEEP VEIN THROMBOSIS (DVT) FOLLOWING A LASER HAIR REMOVAL TREATMENT. I LET HIM KNOW IN MY 18 YEARS OF WORKING WITH THE LIGHT SHEER DEVICE I HAVE NOT EXPERIENCED OR HEARD OF THIS. I THEN SENT AN ADVERSE EVENT FORM TO HIM AND REQUESTED HIM TO FILL IT OUT. THIS TREATMENT WAS THE THIRD TREATMENT RECEIVED BY THIS PATIENT. PT IS A (B)(6) SKIN TYPE II PATIENT BEING TREATED IN THE AXILLA FOR. BROWN MEDIUM COARSE HAIR. SHE WAS TREATED WITH THE XC CHILL TIP. A TEST SPOT WAS DELIVERED PRIOR TO FULL TREATMENT. THE SETTINGS WERE 26J/CM 2 30 MS 805 NM WAVELENGTH. THE CLINICIAN REPORTS NO BLISTERS, BRUISING OR TENDERNESS DURING TREATMENT. BILATERAL AXILLA TREATED, UNILATERAL DVT REPORTED. SHE REPORTED HAVING A DVT TWO DAYS LATER. PT DENIES ANY MEDICATION, OR HEALTH CONCERNS PRIOR. DEVICE WAS SERVICED IN DECEMBER OF 2018. I HAVE PERSONALLY NOT HEARD ABOUT THIS OCCURRING AS A PROVIDER OF THE LS DEVICE. I HAVE REACHED OUT TO OUR GLOBAL CLINICAL LEADERSHIP AND WILL AMEND THIS REPORT IF ADDITIONAL INFORMATION COMES FORWARD." THE LUMENIS HEALTHCARE PROFESSIONAL AND CLINICAL TRAINER DETERMINED THE INJURY AS MODERATE (RANKED WITH 6 OUT OF 10). WHILE THE INFORMATION RECEIVED TO DATE DOES NOT CONFIRM THAT A MALFUNCTION HAD OCCURRED, THE INJURY WAS DEFINED AS 'MODERATE', THE COMPANY IS REPORTING THE EVENT. LUMENIS IS CLOSING THIS COMPLAINT, BUT WILL CONTINUE TO MONITOR THIS FAILURE MODE; COMPLAINT TRENDING WILL CONTINUE TO MONITOR PER GLOBAL COMPLAINT HANDLING SOP (DOC NO. (B)(4)) AND PER POST MARKETING SURVEILLANCE PROCEDURE (DOC NO. (B)(4)).

    Description of Event or Problem · 0

    A USER FACILITY REPORTED THAT ONE PATIENT SUSTAINED A BURN TO THE CHEST AREA (AXILLA) FOLLOWING TREATMENT WITH LUMENIS LIGHTSHEER XC LASER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    794863 LIGHTSHEER XC INTENSE PULSE LIGHT DELIVERY DEVICE GEX LUMENIS LTD LIGHTSHEER XC

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Female Other