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	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	05/14/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No device malfunctions or other noteworthy events occurred during the histotripsy procedure.The treatment to the pancreatic lesion was performed outside the cleared indication for use of the edison histotripsy system, which is indicated for the non-invasive destruction of liver tumors using histotripsy.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.".
Event or Problem Description
On (b)(6) 2026, a 76-year-old male with a history of metastatic renal cell carcinoma, including pancreatic and liver metastases, underwent histotripsy treatment to multiple liver tumors and a single pancreas tumor.The pancreas lesion measured approximately five (5) cm, which was treated with an estimated total planned treatment volume (ptv) of 33 cc, for the purposes of debulking.The tumor was described by the treating physician as highly vascular.Approximately one month after treatment, the patient developed abdominal pain and presented to a local hospital on (b)(6).Abdominal imaging indicated a pseudoaneurysm in the pancreas, the patient underwent embolization on (b)(6).Persistent bleeding was subsequently identified, and a repeat embolization was performed on (b)(6).Due to hemoglobin decline and continued concern for bleeding, empiric sbrt was also performed.The patient was monitored closely following these interventions and was discharged prior to follow-up.At follow-up on (b)(6), the patient was reported to be doing well, with no further evidence of bleeding and exhibited continued clinical improvement.

• 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: 25538685
• Report Number: 3027664504-2026-00024
• Device Sequence Number: 9359117
• Product Code: QGM
• UDI-Device Identifier: 00850006962082
• UDI-Public: 00850006962082
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 06/17/2026

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: 05/18/2026
• Initial Report FDA Received Date: 06/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/21/2025
• 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: 76 YR
• Patient Sex: Male