BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ION

    MDR report key: 24055795 · Received January 13, 2026

    Report

    Report Number
    2955842-2026-00546
    Event Type
    Injury
    Date Received
    January 13, 2026
    Date of Event
    December 18, 2025
    Report Date
    January 13, 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
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS NOT RECEIVED ANY PRODUCT FOR EVALUATION. SYSTEM LOGS ARE NOT AVAILABLE FOR REVIEW.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER COMPLETION OF AN ION TRANSBRONCHIAL LUNG BIOPSY PROCEDURE, THE PATIENT DEVELOPED A PNEUMOTHORAX. THE PHYSICIAN USED A NEEDLE AND CRYO-PROBE DURING THE PROCEDURE. THE REGION BIOPSIED WAS THE RIGHT UPPER LOBE. IT IS UNKNOWN IF THE PATIENT EXPERIENCED SYMPTOMS. THE PNEUMOTHORAX WAS DISCOVERED VIA A POST-PROCEDURE CHEST X-RAY. A CHEST TUBE WAS PLACED. THERE IS NO ALLEGATION THAT A MALFUNCTION OF AN ION SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED, AND IT IS UNKNOWN IF THE EVENT IS RELATED TO THE PROCEDURE. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE ION SYSTEM WORKED AND THERE WAS NO MALFUNCTION. THE PLEURAL-BASED LESION WAS LOCATED IN THE RIGHT UPPER LOBE AND WAS SITUATED ON THE VISCERAL PLEURA. THE INITIAL PNEUMOTHORAX SIZE WAS APPROXIMATELY 3CM APICAL AND 1 CM LATERAL, WITH NO INDICATION OF PROGRESSION. A 14 FR PIGTAIL CHEST TUBE WAS PLACED, AND NO ADDITIONAL MEDICAL INTERVENTIONS SUCH AS MEDICATIONS OR BREATHING TREATMENTS WERE REQUIRED. THE PATIENT REMAINED ASYMPTOMATIC, REPORTING NO SHORTNESS OF BREATH OR CHEST PAIN. A DIAGNOSIS WAS OBTAINED FROM THE BIOPSY, THOUGH DETAILS WERE NOT DISCLOSED. THE PATIENT WAS HOSPITALIZED FOR 24 HOURS FOLLOWING THE EVENT AND WAS SUBSEQUENTLY DISCHARGED HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116319 ION SYSTEM CART EOQ INTUITIVE SURGICAL, INC 380748-65 N/A 00886874116234

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male Hospitalization| R ION ENDOLUMINAL SYSTEM