BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPLENDOR

    MDR report key: 24679018 · Received March 24, 2026

    Report

    Report Number
    1720381-2026-00003
    Event Type
    Injury
    Date Received
    March 24, 2026
    Date of Event
    March 3, 2026
    Report Date
    March 24, 2026
    Manufacturer
    BIOS S.R.L.
    Product Code
    GEX
    PMA / PMN Number
    K243445
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION BIOS RESULTS: BASED ON THE INFORMATION RECEIVED: THE DEVICE WAS INSTALLED ON JANUARY 20, 2026 AND IS UNDER WARRANTY. A SERVICE VISIT WAS INITIATED DUE TO ERROR CODE 22 (SHUTTER ERROR) UNDER WO: (B)(4) HAS BEEN CANCELED DUE TO DUPLICATION). PER THE CLINICAL ENGINEER (CE), HE COMPLETED CORRECTIVE MAINTENANCE CHECKLIST. REPLACED SHUTTER AND SHUTTER BOARD. VERIFIED THAT ERROR 22 NO LONGER POPULATES, VERIFIED THAT SHUTTER WAS OPERATING PROPERLY AT VARYING TEMPOS AND SPEEDS. VERIFIED POWER WAS WITHIN LUMENIS STANDARDS. INSPECTED INTERIOR FOR ANY LOOSE OR DAMAGED WIRING. RETURNED MACHINE TO READINESS CONDITION, READY FOR CUSTOMER USE. IN ADDITION, DURING THE SERVICE VISIT, THE CE NOTED AS FOLLOWS: "I AM WRITING THIS REGARDING THE MAGIC TOUCH SPLENDORX 2.0. I WAS CALLED IN FOR AN ERROR CODE 22 SHUTTER ERROR. BEFORE I COULD GET INTO THE SITUATION WITH THE ERROR CODE, THE FRONT RECEPTIONIST TOLD ME THAT THEY HAD BURNED SOMEONE DURING THEIR MODEL TESTING, SO NOT AN ACTUAL CLIENT OF THEIRS, AND SHE BROUGHT UP A YOUNG WOMAN BY THE NAME OF (B)(6) FROM THE BACK TO SHOW ME PICTURES OF SOMEONE THAT WAS BLISTERED BY THE MACHINE. HOWEVER, THE YOUNG WOMAN NAMED (B)(6) INFORMED ME THAT THEY WERE ACTUALLY USING TOO HIGH OF SETTINGS ON THE DEVICE AND THAT WHEN THE TRAINER WAS HERE USING THE DEVICE EVERYTHING WORKED PERFECTLY WITH NO ISSUES FROM THE DEVICE OR THE PATIENTS. THE FRONT RECEPTIONIST THEN TOLD ME THAT THE OWNER OF THE STORE WAS CURIOUS ABOUT GETTING A NEW DEVICE ALL TOGETHER SINCE THEY HAD ISSUES. I TOLD THEM TO ALLOW ME TO TAKE A LOOK AT THE DEVICE BEFORE ANYTHING OF THAT NATURE CAN BEGIN. I WAS UNABLE TO RECREATE THE ANY ERROR UNLESS I FORCIBLY MOVED THE SHUTTER FROM THE "MISC" SCREEN ON SERVICE MODE WITH THE ALARM STILL ON. I FIRED THE DEVICE IN VARYING TEMPOS IN ATTEMPTS TO RECREATE ANY OF THE SHUTTER BEING STUCK OR NOT MOVED BUT WAS UNABLE TO CREATE ANY ERROR. I ORDERED A NEW SHUTTER AND BOARD IN ATTEMPTS TO QUELL WHATEVER ISSUE THEY MAY HAVE HAD, SM10233954. I JUST WANTED TO KEEP EVERYONE INFORMED WITH WHAT IS HAPPENING MOVING FORWARD WITH THIS DEVICE. " MEANING, CE REPLACED THE SHUTTER AND SHUTTER BOARD ONLY AS AN EXTRA PRECAUTION AND NOT DUE TO SYSTEM MALFUNCTION. DEVICE MALFUNCTION WASN'T THE SUSPECTED CAUSE OF THE ADVERSE EVENT. INCIDENT FORM - RECORDED IN DOC FOLDER. CLINICAL EXPERT REPORT THAT THE INJURY IS SERIOUS (RATED 8/10) PERMANENT INJURY WITH NO IMPAIRMENT. THE LUMENIS CLINICAL HEALTHCARE MANAGER REPORTED AS FOLLOW: "LUMENIS RECEIVED A REPORT OF AN ADVERSE EVENT INVOLVING THE SPLENDOR X FOR LASER HAIR REMOVAL. THE PATIENT IS A MALE WITH LIGHT SKIN, LIKELY FITZPATRICK II-III. THE AE FORM WAS LACKING PERTINENT INFORMATION FOR THOROUGH EVALUATION IN THIS CASE. THIS WAS THE FIRST TREATMENT FOR THE PATIENT, THE BEARD AREA WAS TREATED. TREATMENT SETTINGS ARE REPORTED AS: BLEND MODE, 18MM SPOT, 7/6J, 20/20MS PD. POSTTREATMENT, THE PATIENT REPORTED ERYTHEMA, EDEMA, AND BLISTERING ON THE RIGHT CHIN. HE WAS ADVISED TO APPLY NEOSPORIN AND A "CREAM FROM MEXICO". DURING DEVICE INSPECTION BY A CE, THE PROVIDER REPORTED "USE OF EXCESSIVE FLUENCE" IN THIS CASE. THE SETTINGS REPORTED ABOVE ARE NOT EXCESSIVE FOR THIS SKIN TYPE. THERE IS A DISCREPANCY IN INFORMATION. LIKELY USER ERROR. AS THE INJURY OCCURRED IN ONLY ONE AREA, IT IS POSSIBLE THAT INCIDENTAL DOUBLE PULSING OCCURRED." IN THE INCIDENT FORM IS NOTED THAT THE PHYSICIAN DIDN'T PERFORM THE TEST SPOT. RC: USE ERROR SINCE THE PHYSICIAN DID NOT PERFORM THE TEST SPOT AS INDICATED IN THE UM "MN0205-USB.R3" AND AS REPORTED BY CLINICAL EVALUATION, THE INJURY OCCURRED IN ONLY ONE AREA, IT IS POSSIBLE THAT INCIDENTAL DOUBLE PULSING OCCURRED. ACCORDING TO THE INFORMATION RECEIVED THERE WAS NO DEVICE MALFUNCTION FOUND.

    Description of Event or Problem · 0

    BIOS RECEIVED FROM ITS IMPORTER LUMENI AN ADVERSE EVENT REPORT BY CLINICAL ENGINEER DURING SERVICE VISIT IN THE CLINIC. THE ADVERSE EVENT WAS CAUSED DURING MODEL TESTING THAT HAS BEEN BURNED FOLLOWING TREATMENT BY SPLENDOR X 2.0 DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26986 SPLENDOR FAMILY OF SQUARE EPIL (ALEX, ALEX2, ND:YAG, ALEX+ND:YAG) GEX BIOS S.R.L. SPLENDOR X

    Patients

    Seq Age Sex Outcome Treatment
    1