Sonasource 102-17000-0009Recalls & reported problems
Focus Surgery Inc · Sonasource is comprised of several integrated programmable hardware and software modules that are used to drive and control SonaCare Medical's probes. The console includes all electronics required for user interaction with all probe imaging and treatment functions. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00868108000212), received between Dec 16, 2025 and Jul 8, 2026 — classified as 2 injuries.
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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
Patient problems
- Fistula2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJul 8, 2026Adverse Event Without Identified Device or Use Problem
ON (B)(6) 2026, THE MANUFACTURER WAS MADE AWARE THAT A PATIENT HAD PRESENTED RECTOURETHRAL SYMPTOMS POST TREATMENT. PER THE INFORMATION, PATIENT WAS REFERRED FOR FISTULA REPAIR AND FURTHER EVALUATION.
Patient problems: Fistula
MAUDE report 25753121 ↗InjuryDec 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use 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.
Patient problems: Fistula
MAUDE report 23821331 ↗
Other High Intensity Ultrasound System For Prostate Tissue Ablation devices
- TULSA-PRO 109171Profound Medical Inc · High Intensity Ultrasound System For Prostate Tissue Ablation1 report
- Sonablate 202-17000-0012Focus Surgery Inc · High Intensity Ultrasound System For Prostate Tissue Ablation1 report
- TULSA-PRO PAD-105Profound Medical Inc · High Intensity Ultrasound System For Prostate Tissue Ablation1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page