BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPLENDOR X

    MDR report key: 22893489 · Received August 26, 2025

    Report

    Report Number
    1720381-2025-00005
    Event Type
    Injury
    Date Received
    August 26, 2025
    Date of Event
    July 20, 2025
    Report Date
    August 26, 2025
    Manufacturer
    BIOS S.R.L.
    Product Code
    GEX
    PMA / PMN Number
    K161632
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    BIOS AND THE IMPORTER (B)(4) 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. (B)(4) 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. INVESTIVE ACTIONS AND TIMELINE: ON AUGUST 14, THE SERVICE ENGINEER (CE) TESTED THE DEVICE AND VERIFIED BOTH THE LASER SPOT SIZE AND SHAPE CONFIRMED THAT THEY WERE WITHIN THE ACCEPTABLE LIMITS. ADDITIONALLY, A DIRTY OR DAMAGED 20X20MM FILTER LENS WAS NOTED, AND REPLACEMENT WAS RECOMMENDED. THE SYSTEM HAS BEEN SUCCESSFULLY RETURNED TO THE CUSTOMER. CLINICAL EXPERT ADVISED: "USER ERROR. A SPOT SIZE THAT IS DIRTY AND/OR IN DISREPAIR AS NOTED CAN FOCUS LASER ENERGY INAPPROPRIATELY. IT IS RECOMMENDED THAT ALL ACCESSORIES AND THE DEVICE ARE THOROUGHLY CHECKED PRIOR TO ANY PROCEDURE AND MAINTAINED PER THE IFU. SETTINGS USED WERE NORMAL/CONSERVATIVE PRESETS FOR THAT SKIN TYPE, AND COOLING WAS USED PER PROTOCOL. HOWEVER, THE TEST SPOT WAS NOT PREFORMED PROPERLY. ROOT CAUSE OF PROBLEM: BASED ON THE AVAILABLE INFORMATION, THE ADVERSE EVENT INVOLVED A SERIOUS INJURY THAT WAS NOT CAUSED BY A DEVICE MALFUNCTION BUT APPEARS TO HAVE RESULTED FROM USER ERROR DUE TO POOR MAINTENANCE, IMPROPER HANDLING OF THE DEVICE, AND LIKELY BY CHANGING THE SPOT SIZE MANUALLY INSTEAD OF USING MANUFACTURER'S RECOMMENDATIONS OR PRESETTING. ACCORDING TO THE USER MANUAL (UM), CUSTOMERS ARE REQUIRED TO PERFORM A VISUAL INSPECTION OF THEIR DEVICES AND COMPONENTS BEFORE USE AND REPLACE ANY CONSUMABLE PARTS IF NECESSARY. THEY MUST ALSO CONDUCT ENERGY TESTS PRIOR TO STARTING TREATMENT. MAINTAINING THE DEVICE IN PROPER WORKING CONDITION IS THE CUSTOMER'S RESPONSIBILITY. UPON RECEIVING OF ANY NEW SIGNIFICANT INFORMATION, THE COMPLAINT RECORD WILL BE UPDATED AND A FOLLOW-UP/FINAL REPORTS WILL BE SUBMITTED ACCORDINGLY.

    Additional Manufacturer Narrative · 0

    BIOS AND THE IMPORTER 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. FOLLOW UP AND FINAL INFORMATION: LATER ON, (B)(6) 2025, SERVICE ENGINEER VISITED AND TESTED THIS DEVICE. HE ADVISED:"A SAFETY EVALUATION WAS CONDUCTED FOLLOWING A CUSTOMER REQUEST REGARDING A SPECIFIC INCIDENT INVOLVING A "TYPE 4 SKIN THICK HAIR" BLISTERING ON THE LOWER ARM AFTER FULL ARM TREATMENT. THIS CONDITION OCCURRED A FEW HOURS POST-TREATMENT. COMPREHENSIVE POWER CHECKOUTS WERE EXECUTED, REVEALING A SLIGHTLY "LOW ALEX POWER" SETTING ABOVE 40. MOREOVER, THE "LOWER YAG SHORT PULSES" WERE OBSERVED AT 5 HZ/80. VERIFICATION OF BOTH THE LASER SPOT SIZE AND SHAPE CONFIRMED THAT THEY WERE WITHIN THE ACCEPTABLE LIMITS. HOWEVER, A MINOR MISALIGNMENT WAS DETECTED AT THE VERTICAL OUTPUT; DESPITE THIS, THERE WAS NO CLIPPING, AND THE SHAPE WAS DEEMED SATISFACTORY. THE CUSTOMER PREFERRED TO RETAIN THE CURRENT CONFIGURATION WITHOUT FURTHER ADJUSTMENTS. DEVICE WAS RETURNED IN WORKING CONDITION WITH MINOR DEVIATIONS NOTED ABOVE. CUSTOMER REPORTED NO ADDITIONAL TREATMENT ISSUES. A SECOND VISIT MAY BE REQUIRED IF THE CUSTOMER REQUESTS FLASH LAMP REPLACEMENT TO ADDRESS LOW ALEX POWER. YAG SHORT PULSE OUTPUT AND ALIGNMENT SHOULD ALSO BE RECHECKED AT THAT TIME. (CUSTOMER DECLINED) LENS REPLACEMENT IS ALSO RECOMMENDED BUT NOT MANDATORY. TIMELY SERVICE/MAINTENANCE COULD HAVE MINIMIZED THESE DEVIATIONS." SINCE THE CUSTOMER EVENTUALLY PROVIDED AN INCIDENT FORM, THE REGIONAL CLINICAL EXPERT UPDATED HER CLINICAL EVALUATION AS FOLLOWS: "LUMENIS RECEIVED A REPORT OF AN ADVERSE EVENT INVOLVING THE SPLENDOR X SYSTEM. THE INJURY OCCURRED WHILE PERFORMING LASER HAIR REMOVAL ON THE ARMS WITH THE ALEXANDRITE/YAG BLEND MODE. THE INJURED PATIENT IS A FEMALE FITZPATRICK IV, AGE AND HERITAGE UNSPECIFIED. THIS WAS HER SECOND TREATMENT TO THE AREA, THE FIRST WITHOUT SEQUELAE ON (B)(6) 2025. THE PATIENT DENIED CONTRAINDICATIONS INCLUDING SUN EXPOSURE IN THE 4 WEEKS PRIOR AND IMMEDIATELY POST TREATMENT. CURRENT MEDICATIONS WERE LEFT BLANK ON THE FORM. THE SETTINGS FOR A PATCH TEST BEHIND THE JAW ("A FEW MINUTES") PRIOR TO FULL TREATMENT WERE RECORDED AS BLEND, 20MM SPOT, 4/6J, 3/3PD, COOLING ON, AND MILD ERYTHEMA REPORTED. ON THE INJURED AREA, SETTINGS ARE RECORDED AS 20MM SPOT, 5/7J, PD NOT LISTED, COOLING ON AT LEVEL 6. EVIDENCE OF AN ADVERSE EVENT WAS NOT NOTED AT CONCLUSION OF THE TREATMENT. A HYDRATING "MIST" WAS APPLIED POST TREATMENT. THE PATIENT REPORTED THAT THROUGHOUT THE EVENING POST TREATMENT, SHE DEVELOPED REDNESS, PAIN, AND BLISTERING. PHOTOS DEMONSTRATE DIFFUSE ERYTHEMA, PFE, AND VARYING SIZES OF FLUID FILLED VESICLES ON THE BILATERAL LOWER ARMS. THE PATIENT WAS DIRECTED TO AND SOUGHT CARE WITH A DERMATOLOGIST. THE CUSTOMER REPORTS THAT THE PHYSICIAN DIAGNOSED A BURN DIRECTLY RELATED TO THE LASER TREATMENT. A SYSTEM CHECK WAS DONE, SEE SERVICE RECORDS. THE 20MM SPOT SIZE (USED WITH THIS TREATMENT) WAS DIRTY AND IN DISREPAIR. A REPLACEMENT WAS RECOMMENDED. USER ERROR. A SPOT SIZE THAT IS DIRTY AND/OR IN DISREPAIR AS NOTED CAN FOCUS LASER ENERGY INAPPROPRIATELY. IT IS RECOMMENDED THAT ALL ACCESSORIES AND THE DEVICE ARE THOROUGHLY CHECKED PRIOR TO ANY PROCEDURE, AND MAINTAINED PER THE IFU. SETTINGS USED WERE NORMAL/CONSERVATIVE PRESETS FOR THAT SKIN TYPE, AND COOLING WAS USED PER PROTOCOL. A PATCH TEST USING ENERGIES INTENDED FOR A FULL TREATMENT AND IN THE AREA INTENDED FOR TREATMENT IS RECOMMENDED 48-72 HOURS PRIOR PER THE LITERATURE. THERE ARE SOME PATIENT VARIABLES THAT ARE POSSIBLE, ALTHOUGH NOT DOCUMENTED- VIRAL/BACTERIAL ILLNESS, SUN OR HEAT EXPOSURE (EVEN INCIDENTAL) IMMEDIATELY POST TREATMENT. 6 - SERIOUS INJURY REQUIRING NON-SURGICAL MEDICAL TREATMENT." BASED ON THE AVAILABLE INFORMATION, THE ADVERSE EVENT INVOLVED A SERIOUS INJURY THAT WAS NOT CAUSED BY A DEVICE MALFUNCTION, BUT APPEARS TO BE RESULTED BY USER ERROR DUE TO ANY COMBINATION OF POOR MAINTENANCE, IMPROPER HANDLING OF THE DEVICE. MOREOVER, PER MANUFACTURER'S ENGINEER, CUSTOMERS HAVE A POSSIBILITY TO CHANGE THE SPOT SIZE MANUALLY INSTEAD OF USING MANUFACTURER'S RECOMMENDATIONS OR PRESETTING. THEREFORE, IT CAN BE ADDITIONAL POSSIBLE CAUSE FACTOR FOR THIS AE. ACCORDING TO THE USER MANUAL (UM), CUSTOMERS ARE REQUIRED TO PERFORM A VISUAL INSPECTION OF THEIR DEVICES AND COMPONENTS BEFORE USE, AND REPLACE ANY CONSUMABLE PARTS IF NECESSARY. THEY MUST ALSO CONDUCT ENERGY TESTS PRIOR TO STARTING TREATMENT. MAINTAINING THE DEVICE IN PROPER WORKING CONDITION IS THE CUSTOMER'S RESPONSIBILITY.

    Description of Event or Problem · 0

    (B)(4). IMPORTER, RECEIVED AN ADVERSE EVENT REPORT ON A PATIENT WHO SUSTAINED INJURY FOLLOWING TREATMENT BY SPX DEVICE.

    Description of Event or Problem · 0

    LUMENIS, THE BIOS S.R.L. IMPORTER, 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
    1406845 SPLENDOR X SPLENDOR X ALEX+ND:YAG GEX BIOS S.R.L. SPLENDOR X

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other