BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATINUM 4 MEDICAL LASER

    MDR report key: 22190745 · Received June 11, 2025

    Report

    Report Number
    3006120071-2025-00001
    Event Type
    Injury
    Date Received
    June 11, 2025
    Date of Event
    May 9, 2025
    Report Date
    June 11, 2025
    Manufacturer
    SUMMUS LASER MEDICAL LLC
    Product Code
    ILY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT (B)(4). DOCTOR CLAIMS THAT THE BURN OCCURED ON HIS ARM DUE TO A BROKEN FIBER ASSEMBLY - THE FIBER ASSEMBLY WAS NOT RECEIVED FOR INVESTIGATION - HOWEVER THE LASER DEVICE WAS RETURNED AND THIS WAS EVALUATED. IT WAS CONCLUDED THAT THERE WAS DUST IN THE MODULE AND THIS CAUSED THE MODULE TO HAVE NO OUTPUT AND WAS BURN. THE FIBER ASSEMBLY WAS BURNED AND UPON INSPECTION OF THE MODULE IT WAS BURNT, THIS IS SEEN WHEN THERE IS DUST IN THE BEAM PATH THE DUST CAN COMBUST AND CAUSE BURNING OF THE FIBER ASSEMBLY, WHEN THE FIBER ASSEMBLY IS REMOVED DUST IS ALLOWED TO ENTER THE MODULE AND WHEN THE FIBER ASSEMBLY IS ATTACHED BACK TO THE DEVICE THE DUST WILL HEAT UP AND COMBUST CAUSING THE FIBER ASSEMBLY TO BURN AND NO LONGER FUNCTION. THE DOCTOR DID NOT RETURN THE BROKEN FIBER ASSEMBLY AND NO PHOTOS WERE PROVIDED OF THE BURN. FOLLOW UP WITH THE DOCTOR WAS PERFORMED AND HE STATED HE WAS HEALING WITHOUT ADDITIONAL MEDICAL INTERVENTION. THE INJURY CAN NOT BE CONFIRMED BUT THE FIBER ASSEMBLY WOULD HAVE BROKEN DUE TO DUST IN THE MODULE - THE OWNER MANUAL STATES NOT TO REMOVE THE FIBER ASSEMBLY IN ORDER TO AVOID DUST BUILD UP.

    Description of Event or Problem · 0

    USER (DOCTOR) WAS BURNED BY BROKEN FIBER ASSEMBLY, FIBER ASSEMBLY BROKE AT THE BASE OF TEH HAND PIECE AND BURNED DOCTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2102310 PLATINUM 4 MEDICAL LASER P4 ILY SUMMUS LASER MEDICAL LLC P4 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown