Sonablate 202-17000-0012Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00868108000229), received between Sep 26, 2019 and Sep 26, 2019 — classified as 1 injury.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjurySep 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DR. (B)(6) REPORTED THAT ONE OF HIS PREVIOUS HIFU PATIENTS HAD DEVELOPED A RECTAL FISTULA. PATIENT WAS STATUS POST EXTERNAL BEAM RADIATION THERAPY (EBRT) AND BRACHYTHERAPY. PATIENT HAD A SUPRAPUBIC CATHETER PLACED THE DAY OF THE CASE. AFTER THE SUPRAPUBIC CATHETER WAS DISCONTINUED, PER THE PHYSICIAN, THE PATIENT DEVELOPED DIARRHEA WHICH WAS LATER DIAGNOSED AS A RECTAL FISTULA. DR. (B)(6) PLACED URETHRAL CATHETER WHICH WAS IN PLACE FOR 3 WEEKS AS OF (B)(6) 2019. PER DR. (B)(6) AND VERIFIED VIA A REVIEW OF THE CASE IMAGES, THE PROSTATE AND SVS WERE ABLATED. MANUFACTURER REQUESTED ACCESS TO THE PATIENT'S TREATMENT IMAGES TO REVIEW THE CASE, WHICH DR. (B)(6) WELCOMED. A REVIEW OF THE CASE IMAGES BY MANUFACTURER OCCURRED ON AUGUST 30, 2019 AND RESULTED IN THE FOLLOWING OBSERVATIONS: THE PATIENT HAD A THICKER THAN NORMAL RECTAL WALL, LIKELY FROM PREVIOUS PROSTATE EBRT AND BRACHYTHERAPY. THE PHYSICIAN FOLLOWED POWER RECOMMENDATIONS. THE PHYSICIAN UTILIZED THE 3/6 DUTY CYCLE THROUGHOUT THE CASE. THE EQUIPMENT WORKED AS INTENDED. THE PHYSICIAN DID NOT IGNORE ANY ALARMS OR BLATANTLY MISUSE THE DEVICE.

  Patient problems: Fistula

  MAUDE report 9124115 ↗