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)
Type of Reportable Event	Serious Injury
Event or Problem Description
Histosonics was made aware of an abstract at the hep-dart conference (hassanein, r.T., hefner, a.M., oliver, d., banuelos, m., barakat, f., & hassanein, t.I.(2025).Histotripsy, a novel non-invasive therapy for liver tumors: an outpatient medical management experience.Southern california abdominal cancer group; southern california transplantation institute research foundation; southern california liver centers) in which two patients had post-treatment acute renal injury indicated by elevated creatinine.Per the abstract, the events resolved in 3-7 days with hydration and supportive care.
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: "as reported in other liver directed therapies, multiple or large-volume liver treatments have been associated with acute kidney injury (aki).When planning extensive or multiple treatments, evaluate and monitor the patient for signs of aki.".

• 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: 24028421
• Report Number: 3027664504-2026-00001
• Device Sequence Number: 18353116
• Product Code: QGM
• UDI-Device Identifier: 00850006962006
• UDI-Public: 00850006962006
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K233466
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Literature
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/09/2026

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2025
• Initial Report FDA Received Date: 01/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/08/2024
• 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: Unknown