FOCAL ONE

Description of Event or Problem

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".

Additional Manufacturer Narrative

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).