SONABLATE
Received Jul 17, 2026 · Event occurred Apr 21, 2026
Report 2951226-2026-00003 · MDR key 25855622
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
Patient
NA · Male
- Fistula
Narrative
Additional Manufacturer Narrative
DURING TREATMENT THERE IS A RISK OF DAMAGE TO THE RECTAL WALL THAT CAN LEAD TO FISTULA FORMATION. A SMALL FISTULA MAY HEAL WITH CONSERVATIVE MANAGEMENT, THOUGH A LARGER FISTULA MAY REQUIRE INTERVENTION TO CORRECT. THE MANUFACTURER ENCOURAGES AND INSISTS THAT ALL PRACTITIONERS NEED TO FOLLOW THE USER MANUAL, LABELING, WARNINGS, AND CAUTIONS, AND TO COMPLETE THE REQUIRED TRAINING ON THE BEST TECHNIQUES FOR USING THE DEVICE.
Description of Event or Problem
ON (B)(6) 2026, THE MANUFACTURER WAS MADE AWARE THAT A PATIENT HAD RECTAL FISTULA. REQUEST FOR FURTHER INFORMATION WAS DECLINED.