MAUDE Adverse Event Report: VARIAN MEDICAL SYSTEMS INTELLIBLATE XIMITRY PROBE ASSEMBLY, 13G X 15CM; SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES

Model Number	IB-XPA-1315
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Hematoma (1884); Liver Damage/Dysfunction (1954)
Date of Event	01/29/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
On 26 feb 2026, a physician communicated to a varian medical science liaison (msl) that an adverse event occurred during a microwave ablation performed on (b)(6) 2026.The physician reviewed post-ablation images that were taken based on the patient presenting with extremely high liver values (patient¿s liver values have now returned to normal).The images revealed complete infarction of liver segments 3 and 4.The pre-ablation imaging reviewed by the physician showed that the lesion to be ablated was close to the portal vein.The lesion was ~2.5 cm and he chose a 3.8 by 3.8 ablation zone for 8 min @ 60w.As communicated to the msl, the physician wasn¿t concerned about ablating the portal vein; rather, the clinician¿s concern was a potential heat sink effect and diminished overall ablation margins.
Additional Manufacturer Narrative
The reported event involved a microwave ablation procedure in which an intelliblate ximitry probe assembly (b)(6) (13g x 15cm) was used to treat a patient with stage four metastatic colorectal cancer.Following completion of the procedure, post ablation imaging was reviewed after the patient was noted to have elevated liver values.The patient¿s liver values subsequently returned to normal.Our investigation determined that the microwave probe functioned as intended, and no device malfunction was identified.The device was not returned for evaluation.A review of manufacturing and product records did not reveal any defects or nonconformities that could have contributed to the reported event.This event is not indicative of a device performance issue, and no corrective or preventive actions are warranted at this time.
Event or Problem Description
See completed mw-2026-00009, mfr report number 3008262715-2026-00006.
Additional Manufacturer Narrative
H6- clinical code was incorrectly submitted as 1884 - hematoma.This was corrected to 1954 - liver damage/ dysfunction.This correction does not result in changes to the event description, device evaluation, or reportability determination.No additional changes have been made.

• Brand Name: INTELLIBLATE XIMITRY PROBE ASSEMBLY, 13G X 15CM
• 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. bldg 2; austin, TX 78717 ; 6504246833
• MDR Report Key: 24621355
• Report Number: 3008262715-2026-00006
• Device Sequence Number: 21416008
• Product Code: NEY
• UDI-Device Identifier: 00810563022292
• UDI-Public: (01)00810563022292(11)251027(17)270427(10)32316
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 04/15/2026

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-XPA-1315
• Device Lot Number: 32316
• 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: 02/26/2026
• Supplement Date Received by Manufacturer: 02/26/2026
• Initial Report FDA Received Date: 03/17/2026
• Supplement Report FDA Received Date: 04/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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