BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STELLAR M22

    MDR report key: 22208580 · Received June 15, 2025

    Report

    Report Number
    3021349626-2025-00003
    Event Type
    Injury
    Date Received
    June 15, 2025
    Date of Event
    May 19, 2025
    Report Date
    June 15, 2025
    Manufacturer
    LUMENIS BE LTD
    Product Code
    GEX
    UDI-DI
    07290109144726
    PMA / PMN Number
    K193500
    Adverse Event
    Yes
    Report Source
    Manufacturer 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 PHOTOS HAVE BEEN RECEIVED IN LUMENIS. AN EXAMINATION OF THE SUBJECT DEVICE WAS PERFORMED BY LUMENIS SERVICE ENGINEER AFTER VERIFYING ALL SYSTEM FUNCTIONS INCLUDING OUTPUT ENERGY VERIFICATION OF IPL AND QSW HANDPIECES. BOTH HANDPIECES ARE MEASURING WITHIN TOLERANCE USING A CALIBRATED EXTERNAL ENERGY METER. SET PM REMINDER DATE. VERIFIED SOFTWARE VERSION IS THE LATEST RELEASE. PERFORMED OPERATIONAL SAFETY CHECKS. SYSTEM MEETS MANUFACTURER SPECIFICATIONS AND IS 100% OPERATIONAL AND READY FOR USE. NO DEVICE MALFUNCTION WAS OBSERVED. THE SYSTEM WAS OPERATIONAL AND WAS READY FOR USE. THE DEVICE WAS INSTALLED ON MARCH 12, 2025 AND STILL UNDER WARRANTY. DEVICE MALFUNCTION WASN'T THE SUSPECTED CAUSE OF THE ADVERSE EVENT. A LUMENIS CLINICAL HEALTHCARE DIRECTOR CONCLUDED: "LUMENIS RECEIVED A REPORT OF AN ADVERSE EVENT INVOLVING THE STELLAR M22 IPL. THE INITIAL REPORTER WAS NOT THE PROVIDER HERSELF, AND THE TREATING PROVIDER AND HER PRIMARY CONTACT HAVE BEEN LARGELY UNRESPONSIVE TO REQUESTS FOR INFORMATION. ALL ATTACHED PHOTOS AND A SCREEN SHOT WITH SETTINGS WERE PROVIDED BY THE CLINICAL TRAINER REPORTING THE ADVERSE EVENT. THE CLINICAL TRAINER WAS NOT ONSITE AND DID NOT GIVE GUIDANCE TO SETTINGS OR TREATMENT IN THIS CASE, SHE WAS CONTACTED BY THE TREATING PROVIDER. THE PROVIDER HAS NOT SUPPLIED THE COMPLETED AE FORM, THERE ARE DETAILS PERTAINING TO TREATMENT AND OUTCOME THAT ARE MISSING. THE PATIENT (ALSO THE PROVIDER AS SHE PRACTICED ON HERSELF) USED IPL IN THE HAIR REDUCTION PRESETS TO TREAT THE BIKINI/BRAZILIAN AREA. SHE IS A FITZPATRICK V, AND PHOTOS DEMONSTRATE DARKER SKIN ON THE INGUINAL AREA, CLOSER TO A FITZPATRICK VI. SETTINGS PER THE SCREENSHOT ARE RECTANGLE LIGHTGUIDE, FITZ V PRESETS WITH BLACK COARSE HAIR, 755NM CUTOFF FILTER, 14J, 4.5/120MS TRIPLE PULSE DURATION. THERE WAS NOT A TEST PULSE THAT LUMENIS IS AWARE OF. PHOTOS DEMONSTRATE AREAS OF HEALING TISSUE (BODY AREA NOT IDENTIFIED- BUT REPORTEDLY BIKINI/BRAZILIAN) WITH BOTH HYPER AND HYPOPIGMENTATION. WOUND CARE PRESCRIBED IS NOT IDENTIFIED. THIS IS USER ERROR. TEST PATCH NOT DONE, DARKER TISSUE INAPPROPRIATE FOR IPL. POSSIBLE EFFECTS: PROLONGED/PERMANENT HYPER OR HYPOPIGMENTATION." THE HAZARD SEVERITY WAS RATED BY CLINICAL DIRECTOR AS 8 OUT OF 10 - PERMANENT INJURY WITH NO IMPAIRMENT. ACCORDING TO THE INFORMATION RECEIVED THERE WAS NO DEVICE MALFUNCTION FOUND. REGARDING THE CLINICAL EVALUATION THERE WAS A USER ERROR. TEST PATCH NOT DONE, DARKER TISSUE INAPPROPRIATE FOR IPL. BASED ON 1010197_W RISK ANALYSIS AND REPORT FOR M22 AND STELLAR PLATFORM - SECTION: # 18.1.1 - WRONG OPERATION BY USER. # 21.2.1 - APPLYING SECOND PASS WHILE THE RESPONSE OF THE FIRST PASS IS EXCESSIVE (ERYTHEMA, EDEMA) OR NOT WAITING LONG ENOUGH BETWEEN TEST SPOT AND TREATMENT OR NOT DOING TEST SPOT AT ALL. # 21.3.1 - USING IPL ON SKIN TYPE 6. # 21.4.1 - WRONG USE OF SYSTEM (APPLYING TREATMENT WHEN THE TREATMENT IS CONTRAINDICATED). THE RISKS ARE WITHIN THE ACCEPTABLE RANGE. FINALLY 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 USING IPL HANDPIECE FOLLOWING TREATMENT BY STELLAR DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    570245 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