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	Hyperbilirubinemia (1903); Chills (2191); Lethargy (2560); Thrombosis/Thrombus (4440); Swelling/ Edema (4577)
Date of Event	07/14/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2026, a 69-year-old female with a history of multifocal hepatocellular carcinoma secondary to nash cirrhosis underwent histotripsy of liver tumors in segments ivb and ii for a total planned treatment volume (ptv) of approximately 83.1 cc.The procedure was reported as uneventful, and the patient was admitted for planned post-procedure monitoring.Immediate post-procedure ct demonstrated thrombosis of the recanalized umbilical vein.The patient developed hyperbilirubinemia, transaminitis, lethargy, and chills.Total bilirubin increased from 1.7 mg/dl to a peak of 13.1 mg/dl at approximately 12 hours post procedure, with ast and alt of approximately 800 u/l.Mrcp demonstrated edema along the left bile duct adjacent to the treatment volume.The patient was managed conservatively with laboratory monitoring every six hours; no transfusion, embolization, or biliary intervention was required.She remained hospitalized until postoperative day 7 and was discharged with bilirubin improved to 2.7 mg/dl.Antibiotics were administered for seven days, and eliquis was continued.
Additional Manufacturer Narrative
No device malfunctions or other noteworthy events occurred during the histotripsy procedure.Thrombus, elevated liver functional tests, and edema are known risks associated with histotripsy procedures and are disclosed in the device labeling.

• 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 ; +1(612)351-0361
• MDR Report Key: 50819038
• Report Number: 3027664504-2026-00043
• Device Sequence Number: 18673891
• Product Code: QGM
• UDI-Device Identifier: 00850006962082
• UDI-Public: 00850006962082
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K241902
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/18/2026

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: 08/20/2026
• Initial Report FDA Received Date: 09/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/16/2026
• 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: Other; Hospitalization
• Patient Age: 69 YR
• Patient Sex: Female