MAUDE Adverse Event Report: VARIAN MEDICAL SYSTEMS INTELLIBLATE MICROWAVE ABLATION SYSTEM CONSOLE; SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES

Model Number	HIB0093
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Multiple Organ Dysfunction Syndrome (3261)
Date of Event	08/25/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Ablation was performed at the site.No irregularities of ablation.Ablation was performed close to surgical anastomosis.Ablation was of expected size however it extended to the bowel causing bowel injury and requiring surgery- precision of injured bowel.Patient recovering well.
Additional Manufacturer Narrative
Varian received an initial report on (b)(6) 2025 regarding unexpected intelliblate ablation during a y90 salvage procedure.Additional details were obtained in person by varian staff at the customer site on (b)(6) 2025.According to the treating physician, ablation was performed at the site near a surgical anastomosis.The ablation zone was of expected size; however, it extended to the bowel, resulting in bowel injury and requiring surgical intervention.The patient is currently recovering following surgery.Investigation into device involvement, performance, and potential contributing factors is ongoing.
Event or Problem Description
The following details of the surgery were provided by the treating physician: ablation was performed at the site.No irregularities of ablation.Ablation was performed close to surgical anastomosis.Ablation was of expected size however it extended to the bowel causing bowel injury and requiring surgery- precision of injured bowel.Patient recovering well.
Additional Manufacturer Narrative
This supplemental provides details about how the surgery details were obtained and additional information obtained after the investigation was completed.The investigation and corresponding investigation codes were finalized at investigation closure on december 22, 2025.Corrected: b5 - describe event or problem has been updated to add a statement noting that information was provided by the treating physician.G1 - the manufacturer address is corrected.H6 - investigation codes have been added/updated to reflect the completed evaluation.Manufacturer narrative includes additional narrative related to investigation conclusion: varian received an initial report on october 28, 2025, regarding unexpected intelliblate ablation during a y90 salvage procedure.Additional details were obtained in person by varian staff at the customer site on november 25, 2025.The following details of the surgery were provided by the treating physician: ablation was performed at the site near a surgical anastomosis.The ablation zone was of expected size; however, it extended to the bowel, resulting in bowel injury and requiring surgical intervention.The patient is currently recovering following surgery.Investigation into the device determined the adverse event was not due to the performance of the intelliblate system and the xpa probes but appears to have resulted from the circumstance of the ablation case.

• Brand Name: INTELLIBLATE MICROWAVE ABLATION SYSTEM CONSOLE
• Common Device Name: SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES
• Manufacturer (Section D): VARIAN MEDICAL SYSTEMS; 9825 spectrum dr. bldg 2; austin TX 78717
• Manufacturer Contact: nia van baalen ; 9825 spectrum dr; austin, TX 78717-1028 ; 6504246833
• MDR Report Key: 23660864
• Report Number: 3008262715-2025-00004
• Device Sequence Number: 18412582
• Product Code: NEY
• UDI-Device Identifier: 00810563022278
• UDI-Public: (01)00810563022278(11)250103
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/21/2026

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: HIB0093
• Device Lot Number: INT0086
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/25/2025
• Supplement Date Received by Manufacturer: 11/25/2025
• Initial Report FDA Received Date: 11/26/2025
• Supplement Report FDA Received Date: 01/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown