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	Unspecified Kidney or Urinary Problem (4503)
Date of Event	05/15/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No device malfunctions or other noteworthy events occurred during the histotripsy procedure.This report is being filed due to the extended hospitalization of the patient.
Event or Problem Description
On (b)(6) 2026 a female patient with a history of colorectal cancer metastatic to the liver, received histotripsy treatment to a single lesion in segment iv consisting of four overlapping maximum planned treatment volumes (ptv) for a total ptv of approximately 134 cc.Given the treatment volume, the treating physician was aware of the potential risk for acute kidney injury (aki) and implemented preventive measures during the procedure, including placement of a foley catheter, administration of intravenous fluids throughout the procedure, monitoring of urine output, and close blood pressure monitoring.During the procedure, the patient experienced low urine output but was otherwise clinically stable according to the treating physician.Following treatment, the patient was admitted for observation due to elevated creatinine levels.Neither the baseline nor post-procedure creatinine values were available at the time of filing, so it is unclear if this event was an aki.The patient remained hospitalized for observation and supportive care; renal function remained stable without the need for dialysis or other intervention.The patient was discharged on (b)(6).

• 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 ; 6128038508
• MDR Report Key: 25538684
• Report Number: 3027664504-2026-00023
• Device Sequence Number: 9359116
• Product Code: QGM
• UDI-Device Identifier: 00850006962082
• UDI-Public: 00850006962082
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 06/17/2026

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
• 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: 05/18/2026
• Initial Report FDA Received Date: 06/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/08/2025
• 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
• Patient Sex: Female