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	Abscess (1690); Thrombosis/Thrombus (4440)
Date of Event	06/23/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2026, a 64 year old female patient with a history of colorectal cancer metastatic to the liver received histotripsy treatment to one lesion in hepatic segment ii was treated with two overlapping histotripsy planned treatment volumes (ptvs) for a total ptv of approximately 55.6 cc.Post-procedure imaging revealed left portal vein thrombus and left hepatic infarction.Anti-coagulation therapy was initiated, but no antibiotics were prescribed.On (b)(6), the patient was admitted for abscess involving the left hepatic lobe and a course of iv antibiotics was initiated.A drain was placed on (b)(6) and the patient was discharged on (b)(6).On (b)(6), the patient presented to the emergency department, ultimately resulting in admission.The patient subsequently underwent surgical resection on (b)(6) involving hepatic segments ii and iii to address the abscess.During surgery it was noted that the abscess extended to the abdominal wall.The patient was discharged on (b)(6) with continued home antibiotics and a new drain in place.On (b)(6), the patient had completed antibiotics, but the drain remained in place.Follow-up with infectious disease is scheduled for the week on (b)(6).
Additional Manufacturer Narrative
No device malfunctions or other noteworthy events occurred during the histotripsy procedure.Post-procedural abscess is a known risk disclosed in the device labeling.

• 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: 50184464
• Report Number: 3027664504-2026-00032
• Device Sequence Number: 16028461
• Product Code: QGM
• UDI-Device Identifier: 00850006962082
• UDI-Public: 00850006962082
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K241902
• 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): 08/07/2026

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
• 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: 06/22/2026
• Initial Report FDA Received Date: 08/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/12/2025
• 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: 64 YR
• Patient Sex: Female