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)
Date of Event	01/12/2026
Type of Reportable Event	Serious Injury
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 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.
Event or Problem Description
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.

• 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: 25753121
• Report Number: 2951226-2026-00002
• Device Sequence Number: 16068900
• Product Code: PLP
• UDI-Device Identifier: 00868108000212
• UDI-Public: 00868108000212
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 07/08/2026

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: 06/10/2026
• Initial Report FDA Received Date: 07/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/19/2016
• 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