MAUDE Adverse Event Report: FOCUS SURGERY, INC. SONABLATE; HIGH INTENSITY FOCUSED ULTRASOUND DEVICE

Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Fistula (1862)
Date of Event	01/01/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Dr.(b)(6) reported that one of his previous hifu patients had developed a rectal fistula.Patient was status post external beam radiation therapy (ebrt) and brachytherapy.Patient had a suprapubic catheter placed the day of the case.After the suprapubic catheter was discontinued, per the physician, the patient developed diarrhea which was later diagnosed as a rectal fistula.Dr.(b)(6) placed urethral catheter which was in place for 3 weeks as of (b)(6) 2019.Per dr.(b)(6) and verified via a review of the case images, the prostate and svs were ablated.Manufacturer requested access to the patient's treatment images to review the case, which dr.(b)(6) welcomed.A review of the case images by manufacturer occurred on august 30, 2019 and resulted in the following observations: the patient had a thicker than normal rectal wall, likely from previous prostate ebrt and brachytherapy.The physician followed power recommendations.The physician utilized the 3/6 duty cycle throughout the case.The equipment worked as intended.The physician did not ignore any alarms or blatantly misuse the device.

• Brand Name: SONABLATE
• Common Device Name: HIGH INTENSITY FOCUSED ULTRASOUND DEVICE
• Manufacturer (Section D): FOCUS SURGERY, INC.; 4000 pendleton way; indianapolis IN 46226
• MDR Report Key: 9124115
• Report Number: 2951226-2019-00001
• Device Sequence Number: 2820047
• Product Code: PLP
• UDI-Device Identifier: 00868108000229
• UDI-Public: 00868108000229
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K160942
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/30/2019

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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/30/2019
• Initial Report FDA Received Date: 09/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention