MAUDE Adverse Event Report: HistoSonics, Inc. Edison; Focused Ultrasound System For Non-Thermal, Mechanical Tissue Ablation

Catalog Number	EDNTC1001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Urinary Retention (2119); Hematuria (2558); Hyponatremia (4494)
Date of Event	07/24/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
As part of the boombox post-market clinical study, on (b)(6) 2026, a 72-year-old male patient with a history of hepatocellular carcinoma received a histotripsy treatment to a single tumor in liver segment vi for a total planned treatment volume (ptv) of approximately 18.76 cc.Post-operative day (pod) 3, the patient presented to the emergency department with urinary retention and hematuria.A foley catheter was placed, and laboratory testing revealed a sodium level of 119 meq/l, requiring hospitalization for correction of hyponatremia, reportedly likely secondary to urinary retention.Bladder irrigation was performed to clear the blood clots.Hematuria, urinary retention, and hyponatremia were reported as resolved on pod5, the foley catheter was removed and the patient was discharged that day.
Additional Manufacturer Narrative
No device malfunctions or other noteworthy events occurred during the histotripsy procedure.Hematuria is a known risk associated with histotripsy procedures and is disclosed in the device labeling.Urinary retention is a known risk associated with the use of general anesthesia.The treating physician attributed this as "probably related" to the procedure.Due to hospitalization and potential relatedness, histosonics is reporting these events out of an abundance of caution.

• Brand Name: Edison
• Common Device Name: Focused Ultrasound System For Non-Thermal, Mechanical Tissue Ablation
• Manufacturer (Section D): HistoSonics, Inc.; 16305 36th avenue n.; suite 300; plymouth MN 55446
• Manufacturer (Section G): HistoSonics, Inc; 16305 36th avenue n.; suite 300; plymouth MN 55446
• Manufacturer Contact: leeanne swiridow ; 16305 36th avenue n.; suite 300; plymouth, MN 55446 ; +1(612)351-0361
• MDR Report Key: 50887178
• Report Number: 3027664504-2026-00048
• Device Sequence Number: 9826223
• Product Code: QGM
• UDI-Device Identifier: 00850006962327
• UDI-Public: 00850006962327
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K241902
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/24/2026

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
• Device Catalogue Number: EDNTC1001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2026
• Initial Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/05/2026
• 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: Required Intervention; Hospitalization
• Patient Age: 72 YR
• Patient Sex: Male