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	Intra-Abdominal Hemorrhage (4479)
Date of Event	05/13/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6), 2026, a 55-year-old female patient with a history of neuroendocrine cancer metastatic to the liver received histotripsy treatment to a single lesion in segment vii for a total planned treatment volume (ptv) of approximately 22.4 cc.Post-procedure ct imaging demonstrated contrast pooling contained within the treatment zone, indicating potential intraparenchymal hemorrhage and the patient was admitted for observation.Following the procedure, the patient's hemoglobin decreased to 6.7 g/dl and the patient received two units of packed red blood cells (prbcs) shortly after midnight on may 14th, followed by an additional unit of prbcs on may 15th.Hemoglobin improved to 10.1 g/dl, and the patient was discharged in stable condition on may 16th.The patient had a history of prior peptide receptor radionuclide therapy (prrt) which the treating physician believed may have contributed to the event.
Additional Manufacturer Narrative
No device malfunctions or other noteworthy events occurred during the histotripsy procedure.In response to reports of vascular related complications, histosonics has incorporated the following warning into its labeling: "mechanical injury to critical structures (e.G., vascular structures, liver capsule, bile ducts) may occur when these structures are within the ptv.The likelihood of bleeding and/or mechanical injury may also increase with additional and/or subsequent treatments within a treatment session or across follow-up treatments.".

• 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: 25488427
• Report Number: 3027664504-2026-00022
• Device Sequence Number: 15933154
• Product Code: QGM
• UDI-Device Identifier: 00850006962082
• UDI-Public: 00850006962082
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 06/12/2026

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: 05/13/2026
• Initial Report FDA Received Date: 06/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/13/2025
• 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: Required Intervention; Hospitalization
• Patient Age: 55 YR
• Patient Sex: Female