BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPLENDOR X

    MDR report key: 22768679 · Received August 11, 2025

    Report

    Report Number
    3020611964-2025-00008
    Event Type
    Injury
    Date Received
    August 11, 2025
    Date of Event
    July 24, 2025
    Report Date
    August 11, 2025
    Manufacturer
    BIOS SRL
    Product Code
    GEX
    UDI-DI
    08052049500067
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA
    Reporter Occupation
    505

    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, PATIENT PHOTO. THE CUSTOMER (PHYSICIAN IN CLINIC) REPORTED ON BLISTERING OF THE ARMS AND SUPPLIED A COMPLETED INCIDENT FORM AND PHOTO. LUMENIS CLINICAL EXPERT REVIEWED THE INFORMATION AND ADVISED: "THIS IS GOING TO BE A (SEVERITY) 6 OR 8. I AM AWAITING TO HEAR BACK FROM THE CUSTOMER ON THE PATIENT'S CURRENT CONDITION. BASED ON THE INFORMATION DOCUMENTED BY THE CUSTOMER, PROVIDED IT IS ACCURATE, THERE WAS NOTHING WITH SETTINGS THAT WAS OVERTLY INCORRECT. PRESETS WERE CONSERVATIVE. THE PROVIDER INQUIRED ABOUT SUN DAMAGE AND THE PATIENT DENIED (THIS IS CONTRADICTORY TO THE VERY OLD CONSENT FORM). THE ZIMMER WAS ON AND AT A LEVEL 6. THE PATIENT HAD TOLERATED THE EXACT SAME SETTINGS 1 MONTH PRIOR. THE PHYSICIAN WHO ASSESSED THE PATIENT STATED THAT THIS INJURY WAS A DIRECT CONSEQUENCE OF THE LASER TREATMENT." THEREFORE, THE SEVERITY OF THE INJURY WAS DEFINED AS SERIOUS. THE DEVICE IS SPLENDOR X; GA-5000000:SPXAY23G-212230. IT WAS INSTALLED IN THE FACILITY ON 9/21/2023 AND ACCORDING TO THE DEVICE HISTORY, SINCE THEN THERE IS NO RECORDS OF PERFORMING ANY PREVENTIVE MAINTENANCE (PM) BY LUMENIS, EVEN NOT IN THE PERIOD OF WARRANTY AFTER 1 YEAR. WE STRONGLY RECOMMEND PERFORMING EARLY PREVENTIVE MAINTENANCE (PM) AND TIMELY SERVICE TO KEEP THE DEVICE IN PROPER WORKING CONDITION. THE INITIATIVE AND PAYMENT FOR THESE SERVICES ARE THE CUSTOMER'S RESPONSIBILITY. AS THE DEVICE IS BILLABLE, LUMENIS IS CURRENTLY WAITING TO SEE IF THE CUSTOMER WILL REQUEST SERVICE. THEY HAVEN'T YET APPROVED PAYMENT FOR ANY SERVICE VISIT. SINCE NO ESSENTIAL TECHNICAL INFORMATION WAS RECEIVED WITHIN PERIOD WHICH IS DETERMINED FOR REPORTABILITY IN CANADA (10 DAYS FOR REPORTING SERIOUS INJURY CAUSED BY DEVICE MALFUNCTION), WE CAN NOT CONCLUDE THAT THE INJURY WAS CAUSED BY THE MALFUNCTION OF THE DEVICE. THUS, AT THIS STAGE OF THE INVESTIGATION, LUMENIS IS REPORTING THIS EVENT TO THE HEALTH CANADA IN AN 'ABUNDANCE OF CAUTION' IN A PRELIMINARY MEDICAL DEVICE PROBLEM REPORT (MDPR). MANUFACTURER (BIOS) REPRESENTATIVE REPORTED THAT THEY ALSO SUBMITTED THE PRELIMINARY REPORT AS A MANUFACTURER. SINCE THE INJURY IS SERIOUS, LUMENIS ALSO SUBMITTED THE INITIAL REPORT TO THE FDA AS AN IMPORTER. WE NOTIFIED THE LEGAL MANUFACTURER (BIOS) ON THIS AE AND ADVISED THEM TO CONSIDER IF THIS CASE SHOULD BE REPORTED BY THEM AS A MANUFACTURER. UPON RECEIVING OF ANY NEW SIGNIFICANT INFORMATION, THE COMPLAINT RECORD WILL BE UPDATED AND A FOLLOW-UP/FINAL REPORTS WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 0

    LUMENIS RECEIVED AN ADVERSE EVENT REPORT ON A PATIENT WHO SUSTAINED INJURY FOLLOWING TREATMENT BY SPX DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2135371 SPLENDOR X FAMILY OF SQUARE EPIL (ALEX, ALEX2, ND:YAG, ALEX+ND:YAG) GEX BIOS SRL SPLENDOR X 08052049500067

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other