MAUDE Adverse Event Report: FOCUS SURGERY, INC. SONABLATE; High intensity ultrasound system for prostate tissue ablation

Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Fistula (1862)
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
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.

• Brand Name: SONABLATE
• Common Device Name: High intensity ultrasound system for prostate tissue ablation
• Manufacturer (Section D): FOCUS SURGERY, INC.; 4000 pendleton way; indianapolis IN 46226
• Manufacturer (Section G): FOCUS SURGERY, INC.; 4000 pendleton way; indianapolis IN 46226
• Manufacturer Contact: justin fortner ; 10130 perimeter parkway, suite 410; charlotte, NC 28216 ; 7043324308
• MDR Report Key: 23821331
• Report Number: 2951226-2025-00001
• Device Sequence Number: 15977114
• Product Code: PLP
• UDI-Device Identifier: 00868108000212
• UDI-Public: 00868108000212
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K160942
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/16/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2025
• Initial Report FDA Received Date: 12/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/15/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male