MAUDE Adverse Event Report: VARIAN MEDICAL SYSTEMS, INC INTELLIBLATE MICROWAVE ABLATION SYSTEM CONSOLE

Model Number	IB-CON
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Stomach Ulceration (4488)
Date of Event	01/14/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The physical intelliblate microwave ablation system involved in this event will not be returned to the manufacturer for evaluation.However, the manufacturer has requested and is in the process of obtaining system and ablation log files associated with the reported procedure.Upon receipt, these logs will be reviewed to assess system performance, verify procedural parameters, and determine whether any device related factors may have contributed to the event.At this time, no conclusions can be drawn regarding root cause or device performance pending completion of this log based analysis.A review of the intelliblate microwave ablation system instructions for use (ifu) confirms that soft tissue injury to adjacent structures is a known undesirable side effect associated with microwave ablation procedures.Based on currently available information, the reported gastric ulceration may fall within the known risks identified in the ifu.Supplemental information will be provided as additional data (e.G., logs) become available and further assessment is completed.
Event or Problem Description
During a ct-guided microwave ablation procedure using the intelliblate microwave ablation system, two recurrent hepatocellular carcinoma (hcc) lesions located in the left hepatic lobe were treated per standard protocol with a 3.0 cm target ablation zone at 60 w for 5 minutes each.Post-procedure ct imaging demonstrated ablation zones exceeding the intended dimensions, measuring 3.92 × 4.56 cm for lesion 1 and 4.59 × 2.94 cm for lesion 2.At the 24hour clinical evaluation, the patient was found to have an ulceration of the distal corpus of the stomach (anterior wall, major curvature), classified as forrest iic and assessed as potentially attributable to thermal injury of the gastric inner layer.Intravenous proton pump inhibitor therapy at double the standard dose was initiated.The patient¿s medical history is significant for recurrent hepatocellular carcinoma with prior laparoscopic resection of liver segment ivb (2017), multiple prior thermal ablations (2021, 2023, 2025), and preablation tace, as well as underlying liver cirrhosis childpugh a secondary to resolved hepatitis¿c and hereditary hemochromatosis.The current adverse event occurred in the context of a complex treatment history involving multiple prior hepatic interventions.The event is being investigated to determine whether the observed enlargement of ablation zones and subsequent gastric ulceration represent a device related effect, a procedural factor, or patient specific susceptibility.Based on initial feedback from the treating physician, it is believed that the patient factors contributed to the event and not any malfunctioning of the device.
Additional Manufacturer Narrative
Additional data provided - investigation completed: h6, h11.Corrected data: b5 updated with corrected and additional details.The physical intelliblate microwave ablation system involved in this event was not returned to the manufacturer for evaluation.System and ablation log data were reviewed to evaluate whether the performance or behavior of the intelliblate system or probe may have caused or contributed to the reported event.Review of the available data demonstrated that the system and probe functioned as intended, and no abnormalities or performance issues were identified.A review of the intelliblate microwave ablation system instructions for use (ifu) confirms that soft tissue injury to adjacent structures is a known undesirable side effect associated with microwave ablation procedures.Based on currently available information, the reported gastric ulceration falls within the known risks identified in the ifu.As stated in the intelliblate ximitry probe assembly instructions for use (p1071010-003-c, p.21), the ablation data provided in the ifu were developed at 17°c in ex-vivo animal models, and ablation zone sizes may not be indicative of human clinical outcomes.Based on the information available, the event is attributed to procedural and patient-related factors.The performance of the probe and system did not cause or contribute to the reported event.This assessment is consistent with feedback provided by the treating physician.The patient is unlikely to have long-term health consequences as a result of this injury.
Event or Problem Description
During a ct guided microwave ablation procedure using the intelliblate microwave ablation system, two recurrent hepatocellular carcinoma (hcc) lesions located in the left hepatic lobe were treated per standard protocol with a 3.0 cm target ablation zone at 60 w for 5 minutes each.Post procedure ct imaging demonstrated ablation zones exceeding the intended dimensions, measuring 3.92 × 4.56 cm for lesion 1 and 4.59 × 2.94 cm for lesion 2.At the 24-hour clinical evaluation, the patient was found to have an ulceration of the distal corpus of the stomach (anterior wall, major curvature), classified as forrest iic and assessed as potentially attributable to thermal injury of the gastric inner layer.Intravenous proton pump inhibitor therapy at double the standard dose was initiated.Clipping of the ulcer was performed.The patient¿s medical history is significant for recurrent hepatocellular carcinoma with prior laparoscopic resection of liver segment ivb (2017), multiple prior thermal ablations (2021, 2023, 2025), and pre-ablation tace, as well as underlying liver cirrhosis, child-pugh a secondary to resolved hepatitis c and hereditary hemochromatosis.The current adverse event occurred in the context of a complex treatment history involving multiple prior hepatic interventions.The treating physician stated that he does not perceive the case as a malfunction of the microwave ablation system.He believes patient factors contributed to the event (i.E., hemochromatosis, patient having liver cirrhosis, child-pugh a; some fibrosis, previous ablation area, lower tip segment 3).Therefore, there was minimal separation of liver and surrounding organs.The patient is unlikely to have long-term health consequences as a result of this injury.

• Brand Name: INTELLIBLATE MICROWAVE ABLATION SYSTEM CONSOLE
• Common Device Name: INTELLIBLATE MICROWAVE ABLATION SYSTEM
• Manufacturer (Section D): VARIAN MEDICAL SYSTEMS, INC; 9825 spectrum dr.; bldg. 2; austin TX 78717
• Manufacturer (Section G): VARIAN MEDICAL SYSTEMS, INC; 9825 spectrum dr.; bldg. 2; austin TX 78717
• Manufacturer Contact: nia van baalen ; 9825 spectrum dr.; bldg. 2; austin, TX 78717 ; 6504246833
• MDR Report Key: 24250789
• Report Number: 3008262715-2026-00004
• Device Sequence Number: 13160051
• Product Code: NEY
• UDI-Device Identifier: 00810563022278
• UDI-Public: (01)00810563022278(11)250813
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2026

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 Model Number: IB-CON
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2026
• Supplement Date Received by Manufacturer: 01/15/2026
• Initial Report FDA Received Date: 02/03/2026
• Supplement Report FDA Received Date: 03/19/2026
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown