BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ION

    MDR report key: 24531776 · Received March 6, 2026

    Report

    Report Number
    2955842-2026-15067
    Event Type
    Injury
    Date Received
    March 6, 2026
    Date of Event
    February 11, 2026
    Report Date
    March 6, 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
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS ADVERSE EVENT. THERE IS NO INDICATION THAT THE CUSTOMER REPORTED COMPLICATION OF PNEUMOTHORAX WAS RELATED TO A PRODUCT ISSUE. THERE WAS NO ALLEGATION THAT A MALFUNCTION OF AN ION SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED DURING THE PROCEDURE BASED ON THE REVIEWED CLINICAL FEEDBACK. AN ION PRODUCT WAS NOT RETURNED TO INTUITIVE SURGICAL, INC. (ISI) FOR EVALUATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER AN ION BIOPSY PROCEDURE, THE PATIENT EXPERIENCED A PNEUMOTHORAX. THE ENDOLUMINAL TERRITORY ASSOCIATE (ETA) WAS PRESENT FOR THE PROCEDURE AND MENTIONED THAT THERE WAS A NODULE IN THE LEFT UPPER LOBE. WHILE NAVIGATING INTO THE PATH, IT WAS NOTED THAT THE NODULE WAS NOT SHOWING UP ON RADIAL ENDOBRONCHIAL ULTRASOUND (EBUS), BUT VISIBILITY WAS OBTAINED VIA X-RAY AND IN ION. MULTIPLE ATTEMPTS WERE MADE WITH EBUS TO VISUALIZE THE NODULE AND AFTER AN HOUR AND A HALF OF TRYING DIFFERENT AIRWAYS, THE PHYSICIAN DID A BRONCHOALVEOLAR LAVAGE (BAL) AND FINISHED THE PROCEDURE. AFTER THE PHYSICIAN COMPLETED THE BAL, A CHEST X-RAY WAS DONE, AND THE PHYSICIAN SAW SOME AIR IN THE LUNG. AN ADDITIONAL X-RAY WAS OBTAINED, AND THE PNEUMOTHORAX WAS MORE PREVALENT, SO A CHEST TUBE WAS PLACED. THE ETA STATED THAT THE PATIENT WAS CONSIDERED HIGH RISK AND THAT HER LUNGS WERE VERY FRAGILE; ANYTHING INSERTED WAS PENETRATING TISSUE. HE SPECULATED THAT THE PNEUMOTHORAX EITHER HAPPENED WITH THE RADIAL EBUS OR THE BAL. THE PATIENT WAS ADMITTED FOR OVERNIGHT STAY IN THE HOSPITAL. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE PHYSICIAN STATED THAT BECAUSE OF THE PATIENT'S BREAST IMPLANTS (FROM PREVIOUS RECONSTRUCTION SURGERY FOR BREAST CANCER) AND THE LESIONS' LOCATION IN LEFT UPPER LUNG (LUL), VISUALIZATION AND ACCESS TO THE LESION, WHICH WAS 31MM, WASN'T VISIBLE OR ACCESSIBLE VIA ENDOBRONCHIAL ULTRASOUND (EBUS). THE PHYSICIAN STATED THAT THE PNEUMOTHORAX OCCURRED BECAUSE OF HIS MANY EFFORTS TO TRY AND VISUALIZE AND ACCESS THE LESION WITH ENDOLUMINAL ULTRASOUND (EBUS). THE LOCATION OF THE LESION WAS JUST UNDER THE STERNUM, NEAR THE CHEST WALL, BETWEEN BREAST IMPLANT AND THE RIGHT VENTRICLE. ANESTHESIA WAS CALLED, AND BECAUSE OF THE DIFFICULTY ACCESSING THE LESION, THE PATIENT UNDERWENT GENERAL ANESTHESIA, AND THE LESION WAS ACCESSED VIA GOING THROUGH THE STERNUM. THE PHYSICIAN STATES THERE IS NO OTHER HISTORY OTHER THAN BREAST CANCER, AND THAT THE CANCER IN THE LUNGS IS BREAST. THE PATIENT REMAINED HOSPITALIZED FOR TWO DAYS, THEN WAS DISCHARGED HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25447 ION SYSTEM CART EOQ INTUITIVE SURGICAL, INC 380748-65 N/A 00886874116234

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female Hospitalization| R ION ENDOLUMINAL SYSTEM.