BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ION

    MDR report key: 25119867 · Received May 7, 2026

    Report

    Report Number
    2955842-2026-24173
    Event Type
    Injury
    Date Received
    May 7, 2026
    Report Date
    May 7, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    EOQ
    UDI-DI
    00886874116234
    PMA / PMN Number
    K182188
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A SYSTEM LOG REVIEW COULD NOT BE PERFORMED BECAUSE EVENT DATES WERE NOT PROVIDED.

    Description of Event or Problem · 0

    A REPORT INDICATED THAT 19 PATIENTS DEVELOPED ACID-FAST BACILLUS INFECTIONS DURING A 3-MONTH PERIOD AFTER UNDERGOING ION ENDOLUMINAL PROCEDURES IN ADDITION TO EBUS STAGING. ALL PROCEDURES UTILIZED THE SAME ION SYSTEM, THOUGH THE SITE REMAINED UNCERTAIN ABOUT THE INFECTION SOURCE. NOTE THAT SOME PATIENTS WHO DEVELOPED THIS INFECTION DID NOT GET AN ION PROCEDURE DONE (ONLY EBUS STAGING). TO ADDRESS THIS CONCERN, BOTH THE INTUITIVE SURGICAL, INC. (ISI) ENDOLUMINAL TERRITORY ASSOCIATE (ETA) AND GENESIS ENDOLUMINAL REPROCESSING TRAINER REVIEWED THE SITE'S WORKFLOWS AND REPROCESSING PROTOCOLS. AFTER THE ONSITE REVIEW, THE GENESIS ENDOLUMINAL REPROCESSING TRAINER PROVIDED SUGGESTIONS TO PREVENT AND MINIMIZE THE NUMBER OF INFECTIONS. IN ADDITION, THE CUSTOMER HAS IDENTIFIED EBUS EQUIPMENT AS A POTENTIAL FACTOR AND IS INVESTIGATING THE OLYMPUS DEVICE AS A MORE SIGNIFICANT COMMON ELEMENT, SINCE NOT ALL INFECTED PATIENTS UNDERWENT ION PROCEDURES. ADDITIONALLY, THE SITE WILL BE EXAMINING THE MEDIVATOR, LUBRICANT, AND OTHER SCOPES COMPREHENSIVELY. IMPORTANTLY, NO MALFUNCTIONS WERE REPORTED REGARDING THE ION SYSTEM, INSTRUMENTS, OR ACCESSORIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    337723 ION SYSTEM CART EOQ INTUITIVE SURGICAL, INC 380748-65 UNKNOWN 00886874116234

    Patients

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