BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ION

    MDR report key: 24805904 · Received April 7, 2026

    Report

    Report Number
    2955842-2026-20582
    Event Type
    Injury
    Date Received
    April 7, 2026
    Date of Event
    March 12, 2026
    Report Date
    April 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
    WV, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE WAS CONDUCTED. INVESTIGATION REVEALED THERE WERE NO RELATED SYSTEM ERRORS TO HAVE OCCURRED DURING THE PROCEDURE THAT WAS RELEVANT TO THE REPORTED EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN ION ENDOLUMINAL LUNG BIOPSY PROCEDURE, THE PATIENT DEVELOPED A PNEUMOTHORAX WHICH REQUIRED CHEST TUBE PLACEMENT AND HOSPITALIZATION. THE TARGET NODULE WAS LOCATED ON THE PLEURAL BORDER. THE PNEUMOTHORAX WAS IDENTIFIED MID-PROCEDURE VIA CONE BEAM CT SPIN. A CHEST TUBE WAS PLACED AND THE PATIENT WAS ADMITTED. THE PROCEDURE WAS COMPLETED WITH NO COMPLICATIONS AND/OR DELAYS. THE PNEUMOTHORAX WAS AN EXPECTED COMPLICATION DUE TO THE LESION'S PROXIMITY TO THE PLEURA. THERE IS NO ALLEGATION THAT A MALFUNCTION OF AN ION SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. INTUITIVE SURGICAL, INC. (ISI) MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    867807 ION SYSTEM CART EOQ INTUITIVE SURGICAL, INC 380748-45 N/A 00886874116234

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Hospitalization| R ION ENDOLUMINAL SYSTEM