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 Code	Renal Impairment (4499)
Date of Event	02/06/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2026, a (b)(6) year old male patient with a history of cholangiocarcinoma received histotripsy treatment to five (5) lesions in liver segment 6 for a total planned treatment volume (ptv) of 149.5 cc.Darkening of the patient's urine was observed intra-/post-procedurally, prompting consideration of increased intravenous fluids and diuretics.However, the anesthesia team expressed concern regarding fluid management due to the patient's underlying chronic cardiac condition.The patient was subsequently hospitalized on (b)(6) and required two sessions of dialysis.The patient was discharged on (b)(6), with laboratory values having returned to baseline.
Additional Manufacturer Narrative
No device malfunctions or other noteworthy events occurred during the case.In response to reports of acute kidney injury associated with histotripsy, histosonics has incorporated the following warning into its labeling: "consider patient-specific risk factors for acute kidney injury (aki) and/or renal failure based on clinical history and procedural scenarios that could increase stress on kidney function, including but not limited to hydration status, planned treatment volume and expected use of imaging contrast agents.Consistent with other liver-directed therapies, treatments involving large treatment volumes or multiple treatment sessions may be associated with an increased risk of aki.Evaluate renal risk and monitor for signs of aki before and after treatment.".

• 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: 24622062
• Report Number: 3027664504-2026-00005
• Device Sequence Number: 15913027
• Product Code: QGM
• UDI-Device Identifier: 00850006962082
• UDI-Public: 00850006962082
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 03/17/2026

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: 02/19/2026
• Initial Report FDA Received Date: 03/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/04/2025
• 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: Hospitalization; Required Intervention
• Patient Sex: Male