SONABLATE
Received Apr 26, 2024
Report 2951226-2024-00005 · MDR key 19193145
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
Description of Event or Problem
ON (B)(6) 2024, THE MANUFACTURE WAS MADE AWARE BY COLLEAGUE THAT A PATIENT IN SWEDEN HAD A FISTULA OVER A YEAR AGO. THE YEAR OF EVENT IS 2023 AND THE DAY AND MONTH OF EVENT ARE UNKNOWN. FURTHER INFORMATION WAS REQUESTED.
Additional Manufacturer Narrative
DURING HIFU TREATMENT, THERE IS A RISK OF DAMAGE TO THE RECTAL WALL (RECTAL FISTULA) FROM THE HEAT GENERATED DURING THE TREATMENT. DAMAGE TO THE RECTAL WALL CAN LEAD TO BLEEDING, INFECTION AND INCONTINENCE AND MAY REQUIRE SURGICAL INTERVENTION TO CORRECT. THIS RISK CAN BE MINIMIZED BY CONSTANT MONITORING OF THE TEMPERATURE IN THE PROBE TIP AND BY THE USE OF A COOLING DEVICE TO CONTROL THE TEMPERATURE OF THE PROBE TIP. HOWEVER, THIS HAZARD CANNOT BE AVOIDED COMPLETELY. PATIENTS WHO HAVE HAD PREVIOUS RADIATION TREATMENT FOR PROSTATE DISEASE ARE AT HIGHER RISK FOR RECTAL FISTULA. THE MANUFACTURER ENCOURAGES ALL PRACTITIONERS TO FOLLOW THE USER MANUAL, LABELING, WARNINGS, AND CAUTIONS, AND TO COMPLETE THE REQUIRED TRAINING ON THE BEST TECHNIQUES FOR USING THE DEVICE.