BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FOCAL ONE

    MDR report key: 21707622 · Received March 27, 2025

    Report

    Report Number
    9612448-2025-00001
    Event Type
    Injury
    Date Received
    March 27, 2025
    Date of Event
    February 27, 2025
    Manufacturer
    EDAP TMS FRANCE
    Product Code
    PLP
    PMA / PMN Number
    K172721
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONCLUSION OF EDAP TMS INVESTIGATIONS SHOW THAT THIS FISTULA IS NOT RELATED TO A DYSFUNCTION OF THE DEVICE AND/OR THE PROBE. THE RECOMMENDATIONS OF THE USER MANUAL WERE NOT RESPECTED. IN FACT, WE HAVE AN INFILTRATING RECTAL WALL WITH A FAT LAYER THAT LARGELY REACTS TO THE TREATMENT. THIS RESULTS IN THE THICKENING OF THE RECTAL WALL AND OF A HYPOECHOGENIC AREA (FAT LAYER) EXCEEDING 1 CM AND WHICH SEEMS DIRECTLY RELATED TO THE CREATION OF THE URETHRORECTAL FISTULA. IN ADDITION, THE TREATMENT WAS NOT STOPPED EVEN WITH A PERSISTENT FOGGY AND THEN BARRIER CAVITATION LEADING TO A BLIND TREATMENT (IMPOSSIBLE TO SEE THE PROSTATE CONTOUR, TRAJECTORIES OUTSIDE THE PROSTATE CAPSULA AND FIRST FOCAL POINTS ON THE RECTAL WALL). NOTE THAT THIS TYPE OF CAVITATION ALREADY APPEARS DURING THE TREATMENT OF THE FIRST AREA (RIGHT LOBE).

    Description of Event or Problem · 0

    THERE HAS BEEN A REPORTED FISTULA FROM (B)(6). DOCTOR SENT THE FOLLOWING TEXT MESSAGE TO EDAP TMS (2/27/2025): "UNFORTUNATELY HAVE A PROSTAORECTAL FISTULA ON A RECENT HIFU ((B)(6)) DONE ON (B)(6) 2025".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1438525 FOCAL ONE FOCAL ONE PLP EDAP TMS FRANCE 239320

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other