BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPLENDOR X

    MDR report key: 24996556 · Received April 27, 2026

    Report

    Report Number
    1720381-2026-00006
    Event Type
    Injury
    Date Received
    April 27, 2026
    Date of Event
    March 29, 2026
    Report Date
    April 27, 2026
    Manufacturer
    BIOS S.R.L.
    Product Code
    GEX
    UDI-DI
    08052049500067
    PMA / PMN Number
    K243445
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION BIOS RESULTS: BASED ON THE INFORMATION RECEIVED: THE DEVICE A-5000002US: (B)(6) WAS INSTALLED IN THE FACILITY ON (B)(6) 2026 AND IT'S UNDER WARRANTY. LUMENIS SERVICE ENGINEER VISITED THE FACILITY AND TESTED THIS DEVICE. HE ADVISED AS FOLLOWS: "CONFIRMED PERSISTENT ANOMALY 25 ENERGY ND: YAG RESONATOR GETTING OUT OF RANGE WHILE TESTING AT FLUENCE 30+. PERFORMED LIVE ENERGY CHECK CALIBRATION FOR ND: YAG AND ALEX. ALL ERRORS HAVE CLEARED. ROUTED CABLES AND FIBER PROPERLY. INFORMED CUSTOMER THAT HAVE THE FOOT PEDAL REMOVED FROM ITS PROTECTIVE COVER IS A HAZARD. DEVICE IS GROUNDED AND NO STATIC DISCHARGE WAS SEEN. CLEANED DEVICE. CONFIRMED WATER TANK WAS FULL. PERFORMED ENERGY TIP CHECKS, ALL PASSED. CONFIRMED POWER OUTPUTS ARE WITHIN SPECIFICATION. DEVICE IS READY FOR USE." BIOS HAS REVIEWED THE DATA AND ADVISED AS FOLLOWS: "THE REPORTED TECHNICAL ISSUE CANNOT BE A POTENTIAL CAUSE OF SERIOUS INJURY IF IT REOCCURS, BECAUSE THE ANOMALY 25 OCCURS AS EXPECTED TO AVOID ANOMALOUS ENERGY DELIVERY GRANTING SAFETY. NORMAL OPERATING RANGE IS EXPECTED ENERGY +/- 20% ACCORDING TO CEI EN 60601-2-22. "CUSTOMER MUST PERFORM THE ENERGY CHECK. IT IS MANDATORY AT EACH DEVICE STARTUP. MOREOVER, DURING THE TREATMENT ENERGY IS CONTINUOUSLY MONITORED." DEVICE MALFUNCTION WASN'T THE SUSPECTED CAUSE OF THE ADVERSE EVENT. INCIDENT FORM - RECORDED IN DOC FOLDER; NOT AVAILABLE SINCE NEVER SENT BY CUSTOMER CLINICAL EXPERT REPORT THAT THE RATE OF INJURY IS NOT AVAILABLE SINCE THE CUSTOMER DIDN'T SENT US EVEN ONE INCIDENT FORM AND NO PHOTO. RC: NOT CONFIRMED SINCE THE CUSTOMER DIDN'T SENT US EVEN ONE INCIDENT FORM AND NO PHOTO. SINCE NO ESSENTIAL INFORMATION WAS RECEIVED WITHIN PERIOD WHICH IS DETERMINED FOR REPORTABILITY, BIOS IS REPORTING THIS EVENT TO THE FDA IN AN 'ABUNDANCE OF CAUTION'. SHOULD ADDITIONAL SIGNIFICANT INFORMATION BECOME AVAILABLE, THE COMPLAINT RECORD WILL BE UPDATED ACCORDINGLY AND A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    BIOS RECEIVED FROM THE IMPORTER LUMENIS ON ADVERSE EVENT REPORT ON A PATIENT WHO SUSTAINED SHOCK FOLLOWING TREATMENT BY SPX DEVICE. CUSTOMER ADVISED THAT A DEEP SHOCK TO THE HEAD WAS FELT WHEN CUSTOMERS HAIR BRUSHED THE FIBER. HOWEVER, SINCE THE CUSTOMER DIDN'T SENT US EVEN ONE INCIDENT FORM AND NO PHOTO, WE TREAT THIS CASE AS A SINGLE ISSUE IN CURRENT COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310214 SPLENDOR X FAMILY OF SQUARE EPIL (ALEX, ALEX2, ND:YAG, ALEX+ND:YAG) GEX BIOS S.R.L. SPLENDOR X 08052049500067

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other