BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ION

    MDR report key: 25047330 · Received April 30, 2026

    Report

    Report Number
    2955842-2026-22739
    Event Type
    Injury
    Date Received
    April 30, 2026
    Date of Event
    April 7, 2026
    Report Date
    April 30, 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
    KY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE SHOWED THERE WERE NO RELATED SYSTEM ERRORS TO HAVE OCCURRED DURING THE PROCEDURE THAT WOULD HAVE LIKELY CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. A REVIEW OF THE EVENT WAS CONDUCTED BY AN INTUITIVE SURGICAL, INC. (ISI) MEDICAL OFFICER AND THE FOLLOWING ADDITIONAL INFORMATION WAS PROVIDED: "PATIENT IS AN ELDERLY FEMALE WHO UNDERWENT AN ION PROCEDURE FOR BIOPSY OF A PERIPHERAL RUL LESION. SHE HAD AN UNDERLYING HISTORY OF PFO THAT WAS CLOSED 30 YEARS AGO. DURING THE PROCEDURE, SHE BECAME HYPOXIC AND WENT INTO A CARDIAC ARREST. FOLLOWING 2-3 MINUTES OF CPR, SHE WAS STABILIZED AND ADMITTED TO THE HOSPITAL. AFTER BEING HOSPITALIZED FOR A WEEK, SHE WAS DISCHARGED HOME IN STABLE CONDITION. THERE WAS NO ALLEGATION OF A MALFUNCTION OF THE ION SYSTEM, INSTRUMENT OR ACCESSORIES ASSOCIATED WITH THE REPORTED COMPLICATION. THE AVAILABLE DATA SUGGESTS THAT THE ION SYSTEM DID NOT CONTRIBUTE TO THE ADVERSE EVENT BUT IT IS POSSIBLE THE ADVERSE EVENT WAS RELATED TO THE PROCEDURE INCLUDING ANESTHESIA IN A PATIENT WITH UNDERLYING CARDIOVASCULAR CO-MORBIDITIES. BRONCHOSCOPY AND BIOPSY IS A MINIMALLY INVASIVE PROCEDURE WITH A LOW COMPLICATION RATE AND RARELY ASSOCIATED WITH FATAL COMPLICATIONS. IN A MULTICENTER PROSPECTIVE STUDY OF 20,986 BRONCHOSCOPIES THE TOTAL NUMBER OF ANY COMPLICATIONS WAS REPORTED TO BE 227 (1.08%) WITH 4 TOTAL DEATHS (0.02%). A MULTICENTER STUDY REPORTED 13 (2.2%) COMPLICATIONS WITH NO DEATHS ASSOCIATED WITH 581 CASES. A PROSPECTIVE MULTICENTER INTERNATIONAL STUDY OF 1,215 REPORTED 1 ASSOCIATED DEATH (0.08%). ANOTHER SURVEY BASED STUDY OF 103,978 BRONCHOSCOPIES DESCRIBED 71 CASES (0.068%) OF ASSOCIATED CARDIOVASCULAR EVENTS. 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. 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;71(1). OST DE, ERNST A, LEI X, ET AL. DIAGNOSTIC YIELD AND COMPLICATIONS OF BRONCHOSCOPY FOR PERIPHERAL LUNG LESIONS. RESULTS OF THE AQUIRE REGISTRY. AM J RESPIR CRIT CARE MED. 2016;193(1):68-77. 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. 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 OXYGEN SATURATION DROPPED AND THE MEDICAL TEAM CALLED A CODE BLUE. THE PHYSICIAN REPORTED THE ION SYSTEM FUNCTIONED WITHOUT ISSUES. THE TARGET WAS A PERIPHERAL LESION IN THE RIGHT UPPER LOBE. THE PATIENT, HAD A HISTORY OF HYPERTENSION AND PATENT FORAMEN OVALE CLOSED 30 YEARS PRIOR TO THE ION PROCEDURE, AND WAS ON 81 MG DAILY ASPIRIN WHICH WAS DISCONTINUED 5 DAYS BEFORE THE ION PROCEDURE. WHILE BIOPSIES WERE SUCCESSFULLY OBTAINED, EBUS COULD NOT BE COMPLETED DUE TO CARDIAC ARREST CAUSED BY BRONCHOSPASM. RESUSCITATION LASTED 2-3 MINUTES BEFORE THE PATIENT WAS STABILIZED. SUBSEQUENT ECHOCARDIOGRAM SHOWED NORMAL EJECTION FRACTION. THE PATIENT REMAINED HOSPITALIZED FOR ONE WEEK BEFORE BEING DISCHARGED HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1111502 ION SYSTEM CART EOQ INTUITIVE SURGICAL, INC 380748-61 UNKNOWN 00886874116234

    Patients

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