BEUDAMED
    FDA Adverse Event Death Summary report: N

    INTELLIBLATE MICROWAVE ABLATION SYSTEM CONSOLE

    MDR report key: 24914861 · Received April 17, 2026

    Report

    Report Number
    3008262715-2026-00007
    Event Type
    Death
    Date Received
    April 17, 2026
    Date of Event
    January 30, 2026
    Report Date
    May 13, 2026
    Manufacturer
    VARIAN MEDICAL SYSTEMS
    Product Code
    NEY
    UDI-DI
    00810563022278
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION INTO POTENTIAL DEVICE INVOLVEMENT, DEVICE PERFORMANCE, AND CONTRIBUTING FACTORS IS ONGOING. AT THIS TIME, NO CONCLUSIONS HAVE BEEN REACHED.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL SUBMISSION INCLUDES DETAILS OBTAINED UPON COMPLETION OF THE INVESTIGATION. THE INVESTIGATION AND CORRESPONDING INVESTIGATION CODES WERE FINALIZED AT INVESTIGATION CLOSURE ON APRIL 30, 2026. MANUFACTURER NARRATIVE INCLUDES INVESTIGATION CONCLUSION: THE REPORTED COMPLAINT DID NOT IDENTIFY A DEVICE MALFUNCTION. THE DEVICE WAS NOT AVAILABLE FOR EVALUATION, AS THE EVENT WAS REPORTED SEVERAL WEEKS AFTER THE PROCEDURE. REVIEW OF AVAILABLE ABLATION SYSTEM DATA SHOWED CHANGES IN POWER SETTINGS DURING THE PROCEDURE, WITH CORRESPONDING EXPECTED CHANGES IN TEMPERATURE OUTPUT. DEVICE HISTORY RECORD REVIEW FOR THE APPLICABLE LOT CONFIRMED THE PRODUCT MET ALL FUNCTIONAL AND ELECTRICAL REQUIREMENTS. BASED ON THE AVAILABLE INFORMATION, THE INVESTIGATION DETERMINED THAT THE INTELLIBLATE SYSTEM PERFORMED AS INTENDED. THE PATIENT DEATH WAS DUE TO THE CIRCUMSTANCES OF THE ABLATION CASE AND NOT CAUSED BY THE PERFORMANCE OF THE INTELLIBLATE SYSTEM.

    Description of Event or Problem · 0

    A VARIAN CLINICAL SCIENCE LIAISON (CSL) WAS NOTIFIED ON (B)(6) 2026 OF A PATIENT WHO EXPERIENCED ISSUES FOLLOWING A MICROWAVE ABLATION PROCEDURE PERFORMED ON (B)(6) 2026. THE TREATING PHYSICIAN INFORMED THE CSL THE PATIENT HAD A ¿MUCH LARGER¿ ABLATION ZONE THAN WHAT WAS PREDICTED. THE PHYSICIAN STATED THE PATIENT HAD ISSUES POST PROCEDURE AND IN FURTHER TALKS WITH THE HOSPITAL STAFF PRESENT, THE CSL WAS INFORMED THE PATIENT PASSED AWAY. A CSL, WHO WAS PRESENT DURING THE PROCEDURE ON (B)(6) 2026, PROVIDED DETAILS REGARDING THE PROCEDURE ON (B)(6) 2026. IT WAS CONFIRMED THE PHYSICIAN USED THE MYABLATION GUIDE SOFTWARE (¿MAG¿) TO LOCATE AND TARGET A DIFFICULT-TO-REACH LESION FROM AN EXTREMELY ACUTE AND OFF-PLANE APPROACH. THE PHYSICIAN, AT THE TIME OF THE PROCEDURE, SEEMED VERY PLEASED WITH THE NEEDLE PLANNING, AND GUIDANCE FROM THE MAG PERSPECTIVE. THE INTELLIBLATE SYSTEM DID NOT SHOW ABNORMAL TEMPERATURE CHARTS, AND THE TREATMENT PROTOCOL WAS CONSISTENT WITH TREATING THE LESION WITH APPROPRIATE SIZING. THE CSL WAS NOT PRESENT FOR THE POST-PROCEDURE SCAN. ADDITIONAL QUESTIONS REGARDING THE PROCEDURE AND PATIENT OUTCOME WERE REQUESTED. THE TREATING PHYSICIAN CONFIRMED ON (B)(6) 2026 THAT THE LARGER ABLATION RESULTED IN A LIVER INFARCTION THAT LED TO LIVER FAILURE AND SUBSEQUENT MULTI-ORGAN SYSTEM FAILURE. THE PHYSICIAN CONFIRMED THE ABLATION WAS PERFORMED WITH NO TECHNICAL ISSUES. THE POSITIONING OF THE XPA MICROWAVE PROBES WAS STATED BY THE TREATING PHYSICIAN TO BE ¿PERFECT¿, AND THE OPERATION OF THE MICROWAVE CONSOLE WAS AS EXPECTED.

    Description of Event or Problem · 0

    SEE COMPLETED (B)(4) AND MFR 3008262715-2026-0007.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40904 INTELLIBLATE MICROWAVE ABLATION SYSTEM CONSOLE SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES NEY VARIAN MEDICAL SYSTEMS IB-CON 00810563022278

    Patients

    Seq Age Sex Outcome Treatment
    1