BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THOR PHOTOMEDICINE LTD

    MDR report key: 21653049 · Received March 20, 2025

    Report

    Report Number
    3003899624-2025-00003
    Event Type
    Malfunction
    Date Received
    March 20, 2025
    Date of Event
    February 20, 2025
    Report Date
    March 20, 2025
    Manufacturer
    THOR PHOTOMEDICINE LTD
    Product Code
    ILY
    UDI-DI
    05060494130220
    PMA / PMN Number
    K033923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER REPORTED THAT THE TRIGGER POINT PROBE HAS BEEN TURNING ON INVOLUNTARILY WHEN THE CONTROL UNIT IS SWITCHED ON. THE LASER WILL START WITHOUT MANUALLY PRESSING THE ON/OFF BUTTON. THEY HAVE TRIED THE TRIGGER POINT PROBE IN TWO CONTROL UNITS THAT THEY OWN AND IT INVOLUNTARILY TURNS ON IN BOTH. THEY DO NOT HAVE THIS PROBLEM WITH ANY OTHER PROBE. THE MALFUNCTION IS EASILY IDENTIFIED AND THERE WAS NO ADVERSE EVENT. THOR CONTACTED THE CUSTOMER AND REQUESTED RETURN OF THE PROBE AS SOON AS POSSIBLE. THE DEVICE WAS RETURNED AND INVESTIGATED AND THE ISSUE IS TRACED TO THE CABLE SHORTING AT THE PLUG. THE PROBE SWITCHES AND THE CONTROL UNIT FAULTS WHEN THE CABLE IS MOVED AT THE PLUG END. THOR HAVE ASSESSED THE ISSUE FOR SAFETY CONCERNS. THIS MDR IS BEING SUBMITTED AS THERE IS A POTENTIAL (RISK ASSESSED AS BEING HIGHLY IMPROBABLE) OF POSSIBLE DAMAGE TO THE EYE IF THE USER OR PATIENT'S EYES ARE EXPOSED TO A LASER BEAM IN CLOSE PHYSICAL PROXIMITY (LESS THAN 0.64 METRES) WITHOUT USING THE PROTECTIVE EYEWARE. THIS IS A KNOWN RISK OF LASER EMITTING DEVICES AND THOR INCLUDES INSTRUCTIONS ON USING THE SUPPLIED SAFETY EYEWEAR WHEN USING LASER PROBES.

    Description of Event or Problem · 0

    THE TRIGGER POINT PROBE HAS BEEN TURNING ON INVOLUNTARILY WHEN THE CONTROL UNIT IS SWITCHED ON. THE LASER WILL START WITHOUT MANUALLY PRESSING THE ON/OFF BUTTON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1372164 THOR PHOTOMEDICINE LTD 810NM 200MW STANDARD TIP ISSUE 1 ILY THOR PHOTOMEDICINE LTD S2092 05060494130220

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown