BEUDAMED
    FDA Adverse Event Death Summary report: N

    ION

    MDR report key: 23429628 · Received October 30, 2025

    Report

    Report Number
    2955842-2025-43041
    Event Type
    Death
    Date Received
    October 30, 2025
    Date of Event
    September 29, 2025
    Report Date
    October 30, 2025
    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
    NC, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A SYSTEM LOG REVIEW FOUND THAT NO ERRORS OCCURRED DURING THE PROCEDURE THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE EVENT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED, AND NO RELATED NON-CONFORMANCES WERE IDENTIFIED. A REVIEW OF THE EVENT PERFORMED BY AN INTUITIVE SURGICAL MEDICAL SAFETY OFFICER (MSO) CONCLUDED THAT A PATIENT UNDERWENT AN ION LUNG BIOPSY AND DIED. THE PATIENT REPORTEDLY HAD SIGNIFICANT MEDICAL CO-MORBIDITIES. THERE WAS NO ALLEGATION OF MALFUNCTION OF THE ION SYSTEM, INSTRUMENTS, OR ACCESSORIES. MULTIPLE ATTEMPTS AT OBTAINING FURTHER DATA HAVE BEEN UNSUCCESSFUL. THERE IS INSUFFICIENT INFORMATION TO DETERMINE THE RELATIONSHIP TO THE PROCEDURE OR TO THE DEVICE. BRONCHOSCOPY IS A MINIMALLY INVASIVE PROCEDURE WITH A LOW RISK PROFILE. A RETROSPECTIVE STUDY OF 20,986 BRONCHOSCOPIES REPORTED 4 ASSOCIATED DEATHS (0.02%). ANOTHER PROSPECTIVE MULTICENTER INTERNATIONAL STUDY OF 1,215 REPORTED 1 ASSOCIATED DEATH (0.08%). A RECENT META-ANALYSIS OF NAVIGATIONAL BRONCHOSCOPY IN 10,381 PATIENTS REPORTED AN OVERALL ADVERSE EVENT RATE OF 5.6% WITH 1 DEATH. A CASE SERIES OF ION ROBOTIC ASSISTED BRONCHOSCOPIES PUBLISHED AFTER THE META-ANALYSIS INCLUDING 415 CASES REPORTED NO DEATHS. FOLCH EE, PRITCHETT MA, NEAD MA, ET AL. ELECTROMAGNETIC NAVIGATION BRONCHOSCOPY FOR PERIPHERAL PULMONARY LESIONS: ONE-YEAR RESULTS OF THE PROSPECTIVE, MULTICENTER NAVIGATE STUDY. JOURNAL OF THORACIC ONCOLOGY. 2019. FACCIOLONGO N, PATELLI M, GASPARINI S, ET AL. INCIDENCE OF COMPLICATIONS IN BRONCHOSCOPY. MULTICENTRE PROSPECTIVE STUDY OF 20,986 BRONCHOSCOPIES. MONALDI ARCHIVES FOR CHEST DISEASE. 2009. KOPS SEP, HEUS P, KOREVAAR DA, ET AL. DIAGNOSTIC YIELD AND SAFETY OF NAVIGATION BRONCHOSCOPY: A SYSTEMATIC REVIEW AND META-ANALYSIS. LUNG CANCER. 2023. BROWNLEE AR, WATSON JJJ, AKHMEROV A, ET AL. ROBOTIC NAVIGATIONAL BRONCHOSCOPY IN A THORACIC SURGICAL PRACTICE: LEVERAGING TECHNOLOGY IN THE MANAGEMENT OF PULMONARY NODULES. JTCVS. 2023.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ION ENDOLUMINAL LUNG BIOPSY PROCEDURE AND SUBSEQUENTLY EXPIRED. THE INTUITIVE ENDOLUMINAL SALES REPRESENTATIVE WAS INFORMED THAT THE PATIENT HAD A LOT OF PRIOR ISSUES AND THAT THE PHYSICIAN DID NOT BELIEVE THE ION SYSTEM CAUSED OR CONTRIBUTED TO THE REPORTED DEATH. THERE WAS NO ALLEGATION OF A MALFUNCTION INVOLVING AN ION SYSTEM, INSTRUMENT, OR ACCESSORY. MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION FROM THE PULMONOLOGIST WERE MADE; HOWEVER, NO RESPONSE HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1342091 ION SYSTEM CART EOQ INTUITIVE SURGICAL, INC 380748-65 UNKNOWN 00886874116234

    Patients

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