BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ION

    MDR report key: 24613359 · Received March 16, 2026

    Report

    Report Number
    2955842-2026-16194
    Event Type
    Injury
    Date Received
    March 16, 2026
    Date of Event
    February 19, 2026
    Report Date
    March 16, 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
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WAS NO REPORT OF A MALFUNCTION OF AN ION SYSTEM, INSTRUMENT, OR ACCESSORY. THEREFORE, NO PRODUCTS ARE EXPECTED FOR RETURN TO ISI FOR FAILURE ANALYSIS EVALUATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ION ENDOLUMINAL LUNG BIOPSY PROCEDURE AND DEVELOPED A PNEUMOTHORAX. THE FOLLOWING INFORMATION IS UNKNOWN: THE CAUSE AND SEVERITY OF THE PNEUMOTHORAX, WHEN THE COMPLICATION WAS IDENTIFIED, AND WHAT MEDICAL INTERVENTION (IF ANY) WAS RENDERED AS A RESULT OF THE PNEUMOTHORAX. THERE WAS NO ALLEGATION THAT A MALFUNCTION OF AN ION SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. INTUITIVE SURGICAL, INC. (ISI) HAS MADE MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, AS OF THE DATE OF THIS REPORT, NO NEW INFORMATION HAS BEEN OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    674614 ION SYSTEM CART EOQ INTUITIVE SURGICAL, INC 380748-61 N/A 00886874116234

    Patients

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