MAUDE Adverse Event Report: VARIAN MEDICAL SYSTEMS INTELLIBLATE XIMITRY PROBE ASSEMBLY 15CM; MICROWAVE ABLATION SYSTEM PROBE

Model Number	IB-XPA-1315
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pneumothorax (2012)
Date of Event	10/23/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported event involved a microwave ablation procedure in which the siemens my needle laser was used for planning and placement of the microwave probe.During the procedure, the patient experienced an unintended pneumothorax of the right lung, requiring drain placement.Our investigation determined that the microwave probe functioned as intended, and 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 event.The pneumothorax is a known procedural risk associated with microwave ablation and not indicative of device malfunction.Therefore, no corrective or preventive actions are warranted at this time.
Event or Problem Description
Dr.Was using siemens my needle laser to plan and place the [microwave] needles.After placement, the scan show that the placement was not where the physician had intended and had caused a partial pneumothorax of the right lung.Issues was not with [microwave] system.Dr.Placed a 10f drain and case proceeded without further incident.

• Brand Name: INTELLIBLATE XIMITRY PROBE ASSEMBLY 15CM
• Common Device Name: MICROWAVE ABLATION SYSTEM PROBE
• Manufacturer (Section D): VARIAN MEDICAL SYSTEMS; 9825 spectrum dr.; bldg. 2; austin TX 78717
• Manufacturer Contact: nia van baalen ; 911 hansen way; palo alto, CA 94304-1028 ; 6504246833
• MDR Report Key: 23597670
• Report Number: 3008262715-2025-00002
• Device Sequence Number: 9336969
• Product Code: NEY
• UDI-Device Identifier: 00810563022292
• UDI-Public: (01)00810563022292(11)250805(17)270203(10)31920
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/19/2025

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: 31920
• 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: 10/23/2025
• Initial Report FDA Received Date: 11/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/05/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: IMPACT,MODEL: X.CEED(11330002), SERIAL#: (B)(6).
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male