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	Fever (1858)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Although the attribution is unclear, histosonics is reporting this adverse event out of an abundance of caution given the timing post-histotripsy.Histosonics is unaware of any device malfunctions or other noteworthy events which may have occurred during the case and/or contributed to the patient's re-admission.
Event or Problem Description
Histosonics was made aware of a journal article published within the international journal of surgery, (chan, albert cy et al."prospective analysis on the outcomes of histotripsy for primary and metastatic liver tumours.", 10 nov.2025, doi:10.1097/js9.0000000000003856), which identified a previously unreported patient re-admission due to fever that was resolved after paracetamol medication.

• 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: 23789129
• Report Number: 3027664504-2025-00037
• Device Sequence Number: 10470520
• Product Code: QGM
• UDI-Device Identifier: 00850006962006
• UDI-Public: 00850006962006
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 12/12/2025

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: 11/12/2025
• Initial Report FDA Received Date: 12/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/15/2024
• 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
• Patient Sex: Unknown