SONABLATE
Received Dec 16, 2025
Report 2951226-2025-00001 · MDR key 23821331
Device
Generic name
High Intensity Ultrasound System For Prostate Tissue Ablation
Manufacturer
Focus Surgery, Inc.Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Male
- Fistula
- Fistula
Narrative
Additional Manufacturer Narrative
OF NOTE, THE PATIENT HAD UNDERGONE PREVIOUS RECTAL SURGERY WHICH MAY BE A CONTRIBUTING FACTOR TO THE RISK OF RECTAL DAMAGE. DURING HIFU TREATMENT, THERE IS A RISK OF DAMAGE TO THE RECTAL WALL. ALTHOUGH RARE, IT IS A KNOWN RISK THAT SUCH DAMAGE MAY LEAD TO A RECTAL-URETHRAL FISTULA. A SMALL FISTULA MAY HEAL WITH CONSERVATIVE MANAGEMENT, THOUGH A LARGER FISTULA MAY REQUIRE INTERVENTION TO CORRECT.
Description of Event or Problem
ON 19-NOV-2025, THE MANUFACTURER WAS MADE AWARE THAT A PATIENT HAD DEVELOPED A FISTULA EARLIER IN THE YEAR. ADDITIONAL INFORMATION HAD BEEN REQUESTED.