BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THOR PHOTOMEDICINE LTD

    MDR report key: 21761353 · Received April 3, 2025

    Report

    Report Number
    3003899624-2025-00005
    Event Type
    Malfunction
    Date Received
    April 3, 2025
    Date of Event
    March 6, 2025
    Report Date
    April 3, 2025
    Manufacturer
    THOR PHOTOMEDICINE LTD
    Product Code
    ILY
    PMA / PMN Number
    K033923
    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

    THIS REPORT IS RELATED TO THE REPORTS 3003899624-2025-00004 AND 3003899624-2025-00006. THE ISSUES ARE REPORTED FROM THE SAME HEALTH CARE FACILITY FOR ONE THERAPY SYSTEM THAT CONTAINS THREE TREATMENT PROBES THAT WERE ALLEGEDLY FOUND TO BE OVERHEATING. IN THE CLINICIANS' OWN WORDS: "PATIENTS COMPLAINING OF FEELING LIKE THEY ARE GETTING BURNED AND STAFF SAYS HANDPIECES FEEL HOT. ONE PATIENT ACTUALLY HAD A SMALL BURN MARK. LOWER RIGHT HANDPIECE CONNECTOR THREADS ARE STRIPPED. DUE TO THE NATURE OF OUR PATIENT POPULATION, WHICH INCLUDES INDIVIDUALS WITH CANCER-RELATED SYMPTOMS, PAIN SYNDROMES, AND TENDONITIS, OUR UNIT IS USED EXTENSIVELY THROUGHOUT A TWELVE-HOUR DAY BY SEVERAL THERAPISTS. THIS IS OUR ONLY UNIT, AND FOR SOME OF OUR PATIENTS, IT IS THE PRIMARY TREATMENT THEY RELY ON. UNFORTUNATELY, WE HAVE HAD TO PLACE TREATMENTS ON HOLD FOR NOW. CURRENTLY, TWO OF OUR LASER HEADS HAVE OVERHEATED, CAUSING PATIENT DISCOMFORT, AND LEAVING REDNESS ON THEIR SKIN". THE PRACTITIONER REPORTED THAT ALL THE RED MARKS HAD BEEN MILD, TRANSIENT AND HAD RESOLVED. THE S1160 810 NM 1W CLUSTER (5 X 200 MW) ISSUE 2 TREATMENT PROBE (SERIAL NUMBER (B)(6)) WAS RETURNED TO THOR AND UNDERWENT TEMPERATURE TESTING. IT WAS IDENTIFIED THAT THE TEMPERATURE RISES ABOVE THE SPECIFIED LIMIT OF 41 DEGREES C DURING 10 MINUTES OF CONTINUOUS USE. THE ISSUE WAS TRACED TO WEAR AND TEAR OF THE PROBE CABLE AND RESISTOR.

    Description of Event or Problem · 0

    PATIENTS COMPLAINING OF FEELING LIKE THEY ARE GETTING BURNED AND STAFF SAYS HANDPIECES FEEL HOT. ONE PATIENT ACTUALLY HAD A SMALL BURN MARK. CURRENTLY, TWO OF OUR FOUR LASER HEADS HAVE OVERHEATED, CAUSING PATIENT DISCOMFORT AND LEAVING REDNESS ON THEIR SKIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    613774 THOR PHOTOMEDICINE LTD S1160 810NM 1W CLUSTER (5X200MW) ISSUE 2 ILY THOR PHOTOMEDICINE LTD S1160

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown