BEUDAMED
    FDA Adverse Event Death Summary report: N

    ION

    MDR report key: 23794893 · Received December 12, 2025

    Report

    Report Number
    2955842-2025-48436
    Event Type
    Death
    Date Received
    December 12, 2025
    Date of Event
    October 6, 2025
    Report Date
    December 12, 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
    IL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WAS NO REPORT OF ANY MALFUNCTION OF AN INTUITIVE SYSTEM, INSTRUMENT OR ACCESSORY. SYSTEM LOG REVIEW CONFIRMED NO ERRORS OCCURRED DURING THE PROCEDURE THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE EVENT. A REVIEW OF THE EVENT PERFORMED BY AN INTUITIVE SURGICAL MEDICAL SAFETY OFFICER (MSO) CONCLUDED THAT THE ADVERSE EVENT DESCRIBED IS NOT UNIQUE TO AN INTUITIVE PRODUCT OR PROCEDURE AND THE INTUITIVE PRODUCT COULD NOT HAVE CAUSED OR CONTRIBUTED TO THE ADVERSE EVENT. THE PATIENT UNDERWENT AN ION ENDOLUMINAL BIOPSY OF AN 8.2CM LUNG MASS AS PART OF A CLINICAL STUDY. THE PROCEDURE WAS COMPLETED WITHOUT ISSUE IN 24 MINUTES. THE PATIENT WAS ALREADY HOSPITALIZED PRIOR TO THE BIOPSY AND WAS TRANSFERRED TO ANOTHER HOSPITAL FOR SURGICAL CONSULTATION TWO DAYS AFTER THE PROCEDURE. AFTER FURTHER DISCUSSION, THE PATIENT DECLINED FURTHER INTERVENTIONS AND WAS TRANSITIONED TO HOSPICE AND DIED SHORTLY THEREAFTER EIGHT DAYS AFTER THE BIOPSY. THE DEATH WAS ATTRIBUTED TO METASTATIC CANCER. BASED ON THE AVAILABLE DATA THE DEATH WAS DUE TO UNDERLYING MEDICAL CONDITIONS AND WAS NEITHER PROCEDURE NOR DEVICE RELATED. THE DEATH WAS IDENTIFIED AS PART OF A CLINICAL STUDY. 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

    A PATIENT ENROLLED IN AN ION REGISTRY STUDY UNDERWENT A LUNG BIOPSY, THEN SUBSEQUENTLY DIED SHORTLY POST-PROCEDURE. THE ION PROCEDURE WAS COMPLETED UNEVENTFULLY AND NO MALFUNCTIONS OF THE ION SYSTEM OR ACCESSORIES WERE REPORTED. THE PATIENT HAD BEEN HOSPITALIZED FOR 5 DAYS PRIOR TO THE PROCEDURE DUE TO PAIN, GENERALIZED WEAKNESS, AND RAPID WEIGHT LOSS. THE PATIENT WAS TRANSFERRED TWO DAYS POST-PROCEDURE TO AN OUTSIDE FACILITY FOR A SURGICAL CONSULT. UPON ARRIVAL TO THE NEW FACILITY THE PATIENT DECLINED ANY INTERVENTIONS, REQUESTED HOSPICE CARE, AND PASSED AWAY 8 DAYS POST-PROCEDURE. THE CAUSE OF DEATH WAS REPORTED AS METASTATIC CANCER. PATHOLOGY RESULTS FOUND MALIGNANT NON-SMALL CELL LUNG CANCER. THE STUDY INVESTIGATOR REPORTED THE EVENT AS A SERIOUS ADVERSE EVENT (SAE) RESULTING IN DEATH, NOT RELATED TO THE ION SYSTEM, NOT RELATED TO THE ION PROCEDURE AND DEFINITELY RELATED TO THE PATIENT'S EXISTING CONDITIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2703802 ION SYSTEM CART EOQ INTUITIVE SURGICAL, INC 380748-61 N/A 00886874116234

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male Death DA VINCI INSTRUMENTS AND ACCESSORIES