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	Pulmonary Edema (2020)
Date of Event	03/07/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No device malfunctions or other noteworthy events occurred during the case.
Event or Problem Description
On (b)(6) 2026, a 70-year-old male with a history of gastrointestinal stromal tumor (gist) underwent a second histotripsy procedure targeting a hepatic lesion in segment v, consisting of three overlapping treatments for debulking of a 10 cm lesion (total estimated planned treatment volume (ptv) of 100.5 cc).The patient's medical history is significant for congestive heart failure (chf), diabetes mellitus, and end-stage renal disease on dialysis.Post-procedurally, the patient experienced oxygen desaturation in the post-anesthesia care unit, and imaging demonstrated pulmonary edema.The patient was admitted to the icu, kept overnight for observation, subsequently stabilized and was discharged.The treating physician attributed the edema to a combination of potential overload of peri-operative fluids, anesthesia protocol (including possible hypercapnia or narcotic effect) and premature removal from intubation.According to the treating physician, the event was not related to the device or site of histotripsy.

• 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: 24834918
• Report Number: 3027664504-2026-00012
• Device Sequence Number: 9169118
• Product Code: QGM
• UDI-Device Identifier: 00850006962082
• UDI-Public: 00850006962082
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 04/09/2026

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2026
• Initial Report FDA Received Date: 04/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/20/2025
• 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: Other; Hospitalization
• Patient Age: 70 YR
• Patient Sex: Male