BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ION

    MDR report key: 23340751 · Received October 20, 2025

    Report

    Report Number
    2955842-2025-41807
    Event Type
    Malfunction
    Date Received
    October 20, 2025
    Date of Event
    September 24, 2025
    Report Date
    March 26, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    EOQ
    UDI-DI
    00886874124796
    PMA / PMN Number
    K212048
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE CATHETER ASSOCIATED WITH THIS COMPLAINT AND COMPLETED INVESTIGATIONS. THE CATHETER WAS FOUND TO HAVE A STARTUP FAILURE. THE CATHETER WAS SEATED ON AN IN-HOUSE SYSTEM WHERE IT PASSED INITIALIZATION ON 4 OUT OF 5 INSTALLS, HOWEVER IT FAILED WITH 28009 (FIBER) ON 1 OUT OF 5 INSTALLS. WHEN SUCCESSFULLY INITIALIZED, THE UNIT WAS CAPABLE OF BEING DRIVEN THROUGH THE IN-HOUSE LUNG MAP AND PASSED REGISTRATION. IN LOGS INDICATED THE 28009-ERROR CODE HAD A FAILURE MODE. THE FIELD LOGS FOR SYSTEM EN0775 INDICATE THAT THE CATHETER HAD NO ERROR CODES AND WAS RETURNED WITH 0 REMAINING LIVES. DURING EXTERNAL PHYSICAL AND VISUAL INSPECTIONS, THE CATHETER SHOWED SIGNS OF INPUT DISK FRICTION WHEN MANIPULATED. THE FIBER WAS INSPECTED USING THE SCOPE. THE FIBERS APPEARED TO BE CLEAN AND SMOOTH WITH SIGNS OF FLUID INTRUSION.

    Additional Manufacturer Narrative · 0

    THE INSTRUMENT HAS BEEN EVALUATED BY AN INTUITIVE SURGICAL, INC. (ISI) FAILURE ANALYSIS ENGINEER (FAE). CUSTOMER LOG REVIEW SHOWED THE CATHETER WAS LAST INSTALLED ON 09/24/2025 AND WAS SUCCESSFULLY INITIALIZED BEFORE THE PROCEDURE, WITH NO ERRORS RECORDED. LOGS CONFIRMED THAT CAPACITIVE TOUCH SENSING AND MASTER CONTROL CONSOLE SCROLL WHEEL MOTION CORRECTLY COMMANDED CATHETER INSERTION, AND TRACKBALL MOTION COMMANDED ARTICULATION. THE ACTUAL INSERTION AND ARTICULATION POSITIONS FOLLOWED THE COMMANDED MOVEMENTS AS EXPECTED. PRIMARY FAILURE ANALYSIS SHOWED THE CATHETER PASSED STARTUP TESTING 4 OUT OF 5 INSTALLATIONS ON AN IN-HOUSE SYSTEM AND FAILED ONCE WITH ERROR CODE 28009. ANALYSIS INDICATED THE ERROR WAS LIKELY CAUSED BY A DIRTY FIBER DUE TO INSUFFICIENT CLEANING DURING THE TEST SETUP RATHER THAN A DEVICE FAILURE. SINCE LOGS SHOWED NORMAL CATHETER ARTICULATION AND POSITIONING AND NO ISSUES WERE REPRODUCED DURING TESTING, THE CUSTOMER COMPLAINT COULD NOT BE CONFIRMED OR REPLICATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN ION ENDOBRONCHIAL LUNG BIOPSY PROCEDURE, THE CUSTOMER STATED THAT THE SURGEON EXPERIENCED A SIGNIFICANT AMOUNT OF CATHETER DRIFT. IT WAS STATED THAT DURING THE BREATH HOLD THE CATHETER WOULD DRIFT INFERIORLY. THE REPORTED ISSUE WAS RESOLVED BY REPLACING THE CATHETER. THE DIAGNOSTIC PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2355197 ION CATHETER EOQ INTUITIVE SURGICAL, INC 490305-01 K13241125 0019 00886874124796

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown ION ENDOLUMINAL SYSTEM