BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    104 LED CLUSTER PROBE WAVELENGTH = 660NM & 850NM ISSUE 1

    MDR report key: 18279508 · Received December 6, 2023

    Report

    Report Number
    3003899624-2023-00002
    Event Type
    Malfunction
    Date Received
    December 6, 2023
    Date of Event
    June 17, 2023
    Report Date
    December 6, 2023
    Manufacturer
    THOR PHOTOMEDICINE LTD
    Product Code
    ILY
    PMA / PMN Number
    K033923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    TESTING OF THE 104 LED PROBE DID NOT FIND ANY FAULTS WITH THE PROBE. THOR HAS DONE A TEMPERATURE TEST AND IT IS ALL WORKING AS INTENDED. THOR EXPLAINED TO THE CUSTOMER THAT IT IS POSSIBLY BEING USED AT TOO LONGER CYCLE AT A TIME AND EXPLAINED: THE DUTY CYCLE OF MAX TIME ON = 5MIN. MIN TIME OFF 20MIN. CUSTOMER IS HAPPY WITH THIS EXPLANATION. THIS MDR IS BEING SUBMITTED AS A PART OF A RETROSPECTIVE REVIEW AND REMEDIATION EFFORT BASED ON ENHANCEMENTS MADE TO THE COMPANY'S COMPLAINT HANDLING PROCESSES. THIS EVENT IS BEING FILED IN ACCORDANCE WITH A CAPA WHICH HAS BEEN OPENED TO MANAGE THE ACTIONS RELATED TO REMEDIATION OF COMPLAINT FILES AND ANY REQUIRED MDR REPORTING.

    Description of Event or Problem · 0

    THE CLUSTER HEAD IS OVER HEATING, CAUSING THE DEVICE TO BE TO WARM TO HOLD AND LEAVING RED MARKS ON PATIENTS SKIN. WE HAVE NOTED THAT THE HEAD OF THE THOR DEVICE IS BECOMING HOT TO HANDLE AND LEAVING RED MARKS ON THE PATIENT SKIN; SINCE HAVING RETURNED POST SERVICING. THE OVERHEATING ONLY STARTED AFTER WE RECEIVED IT BACK FROM SERVICING, NOT NOTED PRIOR. WE ONLY USE THE THOR TO TREAT CANCER RELATED LYMPHOEDEMA PATIENTS; PREDOMINANTLY POST BREAST CANCER AND HEAD & NECK CANCER TREATMENT. IN THE COURSE OF ONE TREATMENT SESSION, WHICH IS AROUND 40 - 60 MINUTES WE WOULD PERFORM THREE CYCLES OF LLLT AND FLUOROSCOPY GUIDED MANUAL LYMPHATIC DRAINAGE (FG-MLD). DEPENDENT ON THE AREA TO TREAT, THE CLUSTER PROBE WILL BE IN CONTACT WITH THE PATIENTS SKIN FOR USUALLY 6 - 10 ONE MINUTE INTERMITTENT OR CONTINUES APPLICATIONS; THEN RESTED WHEN THE MLD IS PERFORMED. ON THE ONE DAY WHEN WE HAD TWO PATIENTS BOOKED IN AT THE SAME TIME, THE DEVICE WAS USED MORE, BUT NOT CONTINUOUS, SO DID HAVE TIME TO REST. HOWEVER THE CLUSTER HEAD BECAME ALMOST TOO HOT TO EVEN HANDLE ONLY AFTER THREE REPETITIONS AND LEAVING RED MARKS; STOPPED STRAIGHT AWAY ON COMMENCEMENT OF THE 4TH REPETITION. THE RED MARKS STILL NOTED AT THE END OF THE TREATMENT SESSION; RESOLVED WHEN THE PATIENTS ATTENDED FOR THEIR NEXT TREATMENTS (FOR MLD ONLY) TWO DAYS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258485 104 LED CLUSTER PROBE WAVELENGTH = 660NM & 850NM ISSUE 1 ILY THOR PHOTOMEDICINE LTD S2140

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown