BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ION

    MDR report key: 25074254 · Received May 4, 2026

    Report

    Report Number
    2955842-2026-23716
    Event Type
    Malfunction
    Date Received
    May 4, 2026
    Date of Event
    December 18, 2025
    Report Date
    May 4, 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
    UT, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE AN ION PRODUCT TO PERFORM FAILURE ANALYSIS. THE CATHETER WAS ANALYZED AND FOUND TO HAVE A SENSOR CONNECTOR ISSUE. CATHETER WAS OBSERVED TO HAVE FAILED THE STARTUP TEST WITH 2 INSTANCES OF ERROR 28009 OBSERVED IN THE ERROR LOGS. DURING PRIMARY FAILURE ANALYSIS, THE CATHETER WAS INSTALLED ON AN IN-HOUSE SYSTEM 5X AND PASSED THE STARTUP TEST FOR EACH INSTALL. 28009 ERRORS ARE INDICATIVE OF A FIBER CONNECTION RELATED FAILURE. FLAT (FIELD LOGS ANALYSIS TOOL) WAS USED TO ANALYZE THE LIKELY CAUSE OF THE FIELD 28009 ERRORS AND POINTED TO TERMRL, OR TERMINATION REFLECTION, AS THE LIKELY FAILURE MODE. THE RETURN PRODUCT WAS REVIEWED WITH AN ION DATA ENGINEER. ANALYSIS OF THE LOG FILES SHOWED THAT THE GRATING AMPLITUDE FOR MULTIPLE CORES DIPS NEAR THE TERMINATION, LEADING TO THE BEND DIFFERENCE BEING HIGHEST AT THE TERMINATION. THIS BEND DIFFERENCE DUE TO A DROP IN THE GRATINGS AT THE TERMINATION IS DUE TO POOR LASER COHERENCE WHEN THE GRATINGS WERE WRITTEN DURING MANUFACTURING. THE CATHETER SENSOR WAS ALSO FOUND TO HAVE LOW POWER. A LOW POWER SENSOR IS MORE LIKELY TO FAIL FOR LOW POWER EVEN ON NORMAL POWER SYSTEM WHEN COMPARED WITH A CATHETER SENSOR WITH NORMAL POWER. GIVEN THAT HIGHER POWER SYSTEMS CAN OVERCOME LOW GAIN AND LOW SIGNAL AMPLITUDE AND ALLOW THE CATHETER TO PASS STARTUP TESTS, IT IS LIKELY THAT THE FIELD SYSTEM THE CATHETER WAS INSTALLED ON DURING THE DEVICE INSTALL SUPPLIED LOWER POWER THAN THE POWER SUPPLIED BY THE SYSTEM USED DURING MANUFACTURING, CONTRIBUTING TO STARTUP TEST FAILURES WHEN THE BORDERLINE LOW POWER UNIT WAS INSTALLED. AS A RESULT, THE LOW POWER MAY HAVE ALSO CONTRIBUTED TO THE 28009 ERRORS. ADDITIONAL INFORMATION PROVIDED BY ADVANCE FAILURE ANALYSIS: THE CATHETER WAS FOUND TO HAVE DIRTY FIBERS ON THE SENSOR CONNECTOR. DURING VISUAL INSPECTION, EXCESS MATERIAL WAS FOUND ON TOP OF THE FIBER TERMINATION AT THE CATHETER TIP. DURING PRIMARY FAILURE ANALYSIS, IT WAS OBSERVED THAT THE MATERIAL EDGES WERE PEELING. THIS PEELING WAS ALSO OBSERVED DURING ADVANCED FAILURE ANALYSIS, BUT A SECTION OF THE PEELING MATERIAL IDENTIFIED DURING PRIMARY FAILURE ANALYSIS WAS NO LONGER APPARENT AND HAD LIKELY BECOME DETACHED. THE MATERIAL AT THE TIP WAS FOUND TO BE THE ADHESIVE USED TO POT THE FIBER DURING THE FIBER INTEGRATION STATION IN MANUFACTURING. THE CATHETER WAS RETURNED WITH ALL LIVES REMAINING, INDICATING THAT MANUFACTURING CONTRIBUTED TO THE FAILURE MODE. FROM REVIEW WITH A MANUFACTURING ENGINEER, IT IS LIKELY THAT EXCESS LOCTITE ADHESIVE WAS DISPENSED DURING ASSEMBLY AND THE SUBSEQUENT INSPECTION FOR EXCESS LOCTITE WAS MISSED. SUBSEQUENTLY, IT IS LIKELY THAT HANDLING OF THE CATHETER AFTER PACKAGING AND REPROCESSING AND PRIOR TO A PROCEDURE CAUSED THE EDGES OF THE EXCESS ADHESIVE TO PEEL. THE PROBABLE ROOT CAUSE IS ATTRIBUTED TO DIRTY OR DAMAGED FIBERS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO THE START OF AN ION ENDOBRONCHIAL LUNG BIOPSY PROCEDURE, THE FULLY ARTICULATING CATHETER WAS UNABLE TO CONNECT, HAD AN ERROR CODE. THE DIAGNOSTIC PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391854 ION CATHETER EOQ INTUITIVE SURGICAL, INC 490305-10 K14240909 0026 00886874124796

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown ION ENDOLUMINAL SYSTEM