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	Abdominal Pain (1685); Hematoma (1884); Nausea (1970); Vomiting (2144); Constipation (3274)
Date of Event	02/08/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No device malfunctions or other noteworthy events occurred during the histotripsy procedure.In response to reports of vascular related complications, histosonics has incorporated the following warning into its labeling: "mechanical injury to critical structures (e.G., vascular structures, liver capsule, bile ducts) may occur when these structures are within the ptv.The likelihood of bleeding and/or mechanical injury may also increase with additional and/or subsequent treatments within a treatment session or across follow-up treatments.".
Event or Problem Description
On (b)(6) 2026, a 53-year-old female with metastatic renal cell carcinoma underwent histotripsy to one lesion in liver segment vi (5.6 x 5.8 cm tumor dimension; three overlapping treatment volumes).On (b)(6 2026), the patient presented to the emergency department with worsening right-sided abdominal and back pain, along with nausea, vomiting, and constipation and was admitted.Laboratory results showed mildly elevated liver enzymes (alt 123, ast 74), with normal white blood cell count (6.0), low procalcitonin (0.1), and normal lactate (0.7).Hemoglobin decreased to 11.4 g/dl from the baseline value of 12.2 g/dl.Ct imaging showed a large necrotic mass in the right liver (segments vi/vii), measuring approximately 10 x 7.7 x 14 cm, with internal gas and small areas that could represent minor bleeding.Findings were considered likely related to post-treatment changes.The patient was discharged on (b)(6) 2026.Mri on (b)(6) 2026 showed a large fluid-filled area at the treatment site.On (b)(6) 2026, a percutaneous drain was placed, with output consistent with liquefied hematoma.No blood transfusions were required, and no hemodynamic instability occurred.Per the treating physician, the drain was removed and the patient has completely recovered.

• 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 ; 6123510361
• MDR Report Key: 24984612
• Report Number: 3027664504-2026-00016
• Device Sequence Number: 21452618
• Product Code: QGM
• UDI-Device Identifier: 00850006962082
• UDI-Public: 00850006962082
• 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
• 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): 04/24/2026

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
• 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: 03/26/2026
• Initial Report FDA Received Date: 04/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/21/2025
• 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: 53 YR
• Patient Sex: Female