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	Abdominal Pain (1685); Dyspnea (1816); Perforation (2001); Back pain (4895)
Date of Event	03/19/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6), 2026, a 52-year-old female patient with a history of metastatic granulosa cell tumor involving the liver received histotripsy to multiple hepatic lesions in segments ii, iii, and vi, for a total planned treatment volume (ptv) of 52.48 cc.One of the tumors targeted was adjacent to the stomach.The patient had an extensive oncologic and surgical history, including prior total abdominal hysterectomy with bilateral salpingo-oophorectomy (tah/bso), multiple hepatic resections, peritoneal debulking procedures, and multiple lines of systemic therapy.Radiology review of immediate post-treatment imaging indicated "post-treatment changes in the liver [with] inflammatory changes extend[ing] from segment ii/iii to the gastric wall and obliteration the fat plane [between the liver and stomach]", which was believed to be a superficial injury to the stomach.Following discharge from the post-anesthesia care unit, the patient developed persistent back and upper abdominal pain and shortness of breath, prompting presentation to an outside emergency department on pod0.Imaging at that time demonstrated a focal disruption of the lateral wall of the stomach with adjacent extraluminal air and fluid, consistent with a contained gastric perforation.The patient was initiated on intravenous antibiotics, antifungal therapy, and proton pump inhibitor (ppi) therapy.General surgery was consulted, and given the patient's extensive prior surgical history, conservative, non-operative management was recommended.The patient was subsequently transferred to a tertiary care center for continued management.Per the treating physician, the patient failed to improve with expectant/endoscopic measures and ultimately underwent a partial gastrectomy on (b)(6).The pathology showed a 3 cm defect in the stomach adjacent to the targeted liver tumor.Per the treating physician, the ptv may have included the adjacent stomach.The patient had a very long/thin liver with extensive adhesions that made targeting challenging.The patient recovered well from surgery and was discharged 5 days later.
Additional Manufacturer Narrative
The treating physician documented that the patient was counseled regarding elevated risk of gastric injury due to proximity of one of the targeted liver tumors and provided informed consent to proceed given limited other treatment options.No device malfunctions or other noteworthy events occurred during the histotripsy procedure.The proximity of the histotripsy treatment volume to the gastric wall is consistent with a procedural mechanism for the observed gastric injury.

• 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: 24905557
• Report Number: 3027664504-2026-00013
• Device Sequence Number: 9195829
• 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): 04/16/2026

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: 03/20/2026
• Initial Report FDA Received Date: 04/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/17/2025
• 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: Required Intervention; Hospitalization; Other
• Patient Age: 52 YR
• Patient Sex: Female