BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STELLAR M22

    MDR report key: 22369226 · Received July 1, 2025

    Report

    Report Number
    3020611964-2025-00007
    Event Type
    Injury
    Date Received
    July 1, 2025
    Date of Event
    June 4, 2025
    Report Date
    July 1, 2025
    Manufacturer
    LUMENIS BE LTD
    Product Code
    GEX
    UDI-DI
    07290109144726
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    LUMENIS INVESTIGATED THE REPORTED EVENT BY CONTACTING THE USER FACILITY DIRECTLY. ATTEMPTS BY EMAILS AND PHONE CALLS HAVE BEEN MADE TO OBTAIN; PATIENT TREATMENT SETTINGS, PATIENT INFORMATION AND PATIENT PHOTO. PATIENT PHOTO HAS BEEN RECEIVED IN LUMENIS. THE DEVICE WAS INSTALLED ON MARCH 12, 2025 AND STILL UNDER WARRANTY. SERVICE WAS RECENTLY PERFORMED ON THIS SYSTEM (ON 05/24/2025), AFTER THE FIRST HER (DR. (B)(6)) COMPLAINT (# (B)(4)) AND NO MALFUNCTION FOUND. AS THIS WAS A SECOND SEPARATED TREATMENT PROCEDURE INCLUDING ADVERSE EVENT, LUMENIS DECIDED TO CHECK THE SYSTEM AGAIN. THE SYSTEM WAS CHECKED ON JUNE 27, 2025, ACCORDING TO CE THE SYSTEM WAS CHECKED PER LUMENIS STELLAR M22 SERVICE MANUAL. VERIFIED AUTODETECTION OF LIGHT GUIDES AND EXPERT FILTERS. VERIFIED ENERGY OUT OF IPL AND QSW HANDPIECES. ALL ENERGY IS WITHIN MANUFACTURER TOLERANCES. PERFORMED OPERATIONAL SAFETY CHECKS. NO DEVICE MALFUNCTION WAS OBSERVED. THE SYSTEM WAS OPERATIONAL AND WAS READY FOR USE. DEVICE MALFUNCTION WASN'T THE SUSPECTED CAUSE OF THE ADVERSE EVENT. IN ADDITION, DISTRICT SALES MANAGER MADE SEVERAL ATTEMPTS TO REACH THE ACCOUNT TO DISCUSS THE CUSTOMER'S COMMERCIAL CONCERNS, BUT RECEIVED NO RESPONSE. SINCE NO INCIDENT FORM OR TREATMENT SETTINGS RECEIVED IN LUMENIS, CLINICAL EVALUATION WAS PERFORMED BASED ON PATIENT PHOTO ONLY. ACCORDING TO CLINICAL EXPERT, THE CAUSE IS NOT ESTABLISHED DUE TO INSUFFICIENT ESSENTIAL INFORMATION. THE PATIENT SUSTAINED A SERIOUS INJURY, RATED 8 OUT OF 10 IN SEVERITY - PERMANENT INJURY WITH NO IMPAIRMENT. PER THE CLINICAL EXPERT, THERE WAS ANOTHER COMPLAINT FROM THE SAME PATIENT, HOWEVER NO INCIDENT FORM OR INJURY PHOTO HAS BEEN SENT TO LUMENIS. THUS, NO ADDITIONAL COMPLAINT WAS FORMALLY OPENED. ACCORDING TO THE INFORMATION RECEIVED THERE WAS NO DEVICE MALFUNCTION FOUND. REGARDING THE CLINICAL EVALUATION THE CAUSE IS NOT ESTABLISHED DUE TO INSUFFICIENT ESSENTIAL INFORMATION. PROBABLY, THERE WAS A USER ERROR. BASED ON (B)(4) RISK ANALYSIS AND REPORT FOR M22 AND STELLAR PLATFORM - SECTION #18.1.1 - WRONG OPERATION MADE BY USER, THE RISK IS WITHIN THE ACCEPTABLE RANGE. THE HAZARD SEVERITY WAS RATED AS SERIOUS INJURY. THEREFORE, THIS CASE WAS DETERMINED AS REPORTABLE TO THE FDA. 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

    LUMENIS RECEIVED AN ADVERSE EVENT REPORT ON A PATIENT WHO SUSTAINED INJURY ON THE LEFT LATERAL FOREHEAD USING IPL HANDPIECE FOLLOWING TREATMENT BY STELLAR DEVICE. THIS IS A SECOND INJURY OF THE SAME PATIENT (USER FACILITY HERSELF - DR. (B)(6)) THAT HAS BEEN HANDLED THROUGH COMPLAINT #(B)(4). THIS WAS DURING ANOTHER TREATMENT USING DIFFERENT SETTINGS ON A DIFFERENT DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1381960 STELLAR M22 STELLAR M22 FOR INTENSE PULSED LIGHT (IPL) AND LASER SYSTEM GEX LUMENIS BE LTD STELLAR 07290109144726

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other