BEUDAMED
    FDA Adverse Event Death Summary report: N

    ION

    MDR report key: 22032686 · Received May 15, 2025

    Report

    Report Number
    2955842-2025-20837
    Event Type
    Death
    Date Received
    May 15, 2025
    Date of Event
    April 18, 2025
    Report Date
    April 18, 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
    AL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE ION SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE FOUND NO RELATED SYSTEM ERRORS OCCURRED DURING THE PROCEDURE THAT WERE RELEVANT TO THE REPORTED EVENT. A REVIEW OF THE EVENT PERFORMED BY AN INTUITIVE SURGICAL MEDICAL SAFETY OFFICER (MSO) CONCLUDED THAT THE PATIENT UNDERWENT AN ION BRONCHOSCOPY, AND DURING NAVIGATION AND REBUS IMAGING, PRIOR TO BIOPSY, THE PATIENT DEVELOPED HYPOTENSION. EFFORTS AT RESUSCITATION WERE UNSUCCESSFUL AND THE PATIENT DIED. THERE WERE NO REPORTED MALFUNCTIONS OF THE ION SYSTEM, INSTRUMENTS OR ACCESSORIES. NO FURTHER DATA IS AVAILABLE DESPITE MULTIPLE EFFORTS. BASED ON THE AVAILABLE DATA THE EVENTS WERE PROCEDURE RELATED AND NOT DEVICE RELATED. 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 DURING AN ION ENDOLUMINAL LUNG BIOPSY PROCEDURE, THE PATIENT'S BLOOD PRESSURE DROPPED SIGNIFICANTLY, CAUSING HEMODYNAMIC INSTABILITY LEADING TO DEATH. THE PROCEDURE INVOLVED ION NAVIGATION AND RADIAL ENDOBRONCHIAL ULTRASOUND (REBUS), IT WAS INTERRUPTED BEFORE THE BIOPSY COULD BE PERFORMED. APPROXIMATELY 10-15 MINUTES INTO NAVIGATION, THE ANESTHESIOLOGIST INFORMED THE PROCEDURE TEAM OF THE PATIENT¿S ¿DANGEROUSLY LOW¿ BLOOD PRESSURE. THE ION SYSTEM WAS UNDOCKED, AND CARDIOPULMONARY RESUSCITATION WAS INITIATED. THE PATIENT WAS PRONOUNCED DEAD APPROXIMATELY 45 MINUTES LATER. THERE WAS NO REPORTED DEVICE MALFUNCTION ASSOCIATED WITH THE EVENT. MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION FROM THE PHYSICIAN WERE MADE; NO RESPONSE HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1909073 ION SYSTEM CART EOQ INTUITIVE SURGICAL, INC 380748-65 N/A 00886874116234

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Female Death| R DA VINCI INSTRUMENTS AND ACCESSORIES