BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ION

    MDR report key: 21916446 · Received April 28, 2025

    Report

    Report Number
    2955842-2025-17301
    Event Type
    Malfunction
    Date Received
    April 28, 2025
    Date of Event
    April 10, 2025
    Report Date
    April 10, 2025
    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
    NJ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL INC. (ISI) RECEIVED THE FULLY ARTICULATING CATHETER FOR FAILURE ANALYSIS INVESTIGATION. THE INSTRUMENT WAS ANALYZED AND WAS FOUND TO HAVE A TORN LINER. THE TORN LINER LOCATION W DETERMINED ON TWO LOCATIONS. THE FIRST LOCATION WAS FOUND AT 9.84MM FROM THE SHAFT¿S DISTAL TIP TO WHERE THE PIECE OF THE TORN LINER WAS STICKING OUT FROM DISTAL TIP, NO MISSING DEBRIS/FRAGMENTS WAS OBSERVED. SECOND LOCATION WAS FOUND AT 19.29MM FROM THE DISTAL TIP. HOWEVER, DURING THE FULL CONTINUITY LEAKAGE TEST, THERE WERE NO FAILURES OBSERVED. THE CATHETER PASSED FULL CONTINUITY LEAKAGE TEST TWICE WITH NO ISSUE (BOTH AREA OF THE TORN LINER DID NOT CAUSE ANY CONTINUITY FAILURE).

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE CATHETER; HOWEVER, FAILURE ANALYSIS IS STILL ONGOING. ADDITIONAL INFORMATION IS BEING GATHERED TO DETERMINE THE CONTRIBUTION OF THE DEVICE TO THE CUSTOMER REPORTED ISSUE.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO AN ION ENDOBRONCHIAL LUNG BIOPSY PROCEDURE, WHEN PROCEDURALIST WAS PLACING CATHETER INTO ETT, SHE NOTICED ON THE MONITOR THAT THERE WAS SOME FRAGMENTS AT THE TIP OF THE CATHETER. WE ATTEMPTED TO CLEAN THE TIP OF THE CATHETER ASSUMING IT WAS SOME DEBRIS FROM A CLOTH. AFTER FURTHER INSPECTION, BY REMOVING THE VISION PROBE FROM THE CATHETER, A TEAR WITHIN THE SHEATH WAS DISCOVERED. THE DIAGNOSTIC PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL INC. (ISI) FOLLOWED UP WITH THE CUSTOMER TO CONFIRM THAT NO FRAGMENTS FELL INTO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1596731 ION CATHETER EOQ INTUITIVE SURGICAL, INC 490305-01 S15241212 0054 00886874124796

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown ION ENDOLUMINAL SYSTEM.