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	Hematoma (1884)
Date of Event	07/15/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2026, a 59-year-old female patient with a history of colorectal cancer metastatic to the liver received histotripsy treatment to a single lesion in liver segment vi which was treated with two overlapping histotripsy planned treatment volumes (ptv) for a total ptv of 67 cc.Patient had previous histotripsy to the same tumor on (b)(6) 2025.The treating physician elected to modify/adjust the histotripsy treatment parameters, including depth (e.G., mark distance from the body wall to target), and implemented manual cooling time.Post-procedure, the patient developed hemorrhagic shock and was admitted to the icu the same day.Post-procedural ct showed subcapsular hepatic hematoma with bleeding into the peri-nephric fat.Of note, the treating physician disclosed that the tumor may have extended beyond the liver capsule.The patient received a transfusion of two (2) units of packed red blood cells, and vasopressor support.The patient was discharged in stable condition on (b)(6) 2026 and as of (b)(6) 2026, they have fully recovered with normalization of labs.
Additional Manufacturer Narrative
No device malfunctions or other noteworthy events occurred during the histotripsy procedure.The post-procedural hematoma is consistent with the labeled risk of mechanical injury to the liver capsule when vascular structures or the liver capsule are within or adjacent to the planned treatment volume.The edison system labeling includes the following warning statement: "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 increase with additional and/or subsequent treatments within a treatment session or subsequent session.In cases where the tumor violates the liver capsule and/or the liver capsule is compromised from prior intervention or therapy, bleeding events may include intraperitoneal hemorrhage, which can be severe and potentially lead to death.".

• 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: 50202094
• Report Number: 3027664504-2026-00035
• Device Sequence Number: 16020963
• Product Code: QGM
• UDI-Device Identifier: 00850006962082
• UDI-Public: 00850006962082
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): 08/11/2026

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: 07/15/2026
• Initial Report FDA Received Date: 08/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/10/2025
• 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; Required Intervention
• Patient Age: 59 YR
• Patient Sex: Female