BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ION

    MDR report key: 22620687 · Received July 25, 2025

    Report

    Report Number
    2955842-2025-31421
    Event Type
    Injury
    Date Received
    July 25, 2025
    Date of Event
    June 30, 2025
    Report Date
    June 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
    GA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE IS NO ALLEGATION THAT A MALFUNCTION OF AN ION SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. 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: A PATIENT OF UNKNOWN AGE UNDERWENT AN ION BRONCHOSCOPY PROCEDURE. THE PATIENT DEVELOPED VENTRICULAR TACHYCARDIA AND THE PROCEDURE WAS ABORTED. NO BIOPSIES WERE OBTAINED. THE PATIENT WAS HOSPITALIZED AND MONITORED OVERNIGHT THEN DISCHARGED HOME THE NEXT DAY. PAST HISTORY WAS NOTABLE FOR AIDS, CORONARY ARTERY DISEASE, ATRIAL FIBRILLATION AND OTHER NON-SPECIFIED HEART DISEASE. BASED ON THE AVAILABLE DATA THE REPORTED EVENTS WERE LIKELY PROCEDURE RELATED IN PATIENT WITH SIGNIFICANT UNDERLYING CARDIOVASCULAR CO-MORBIDITIES AND NOT DEVICE RELATED. BRONCHOSCOPY AND BIOPSY IS A MINIMALLY INVASIVE PROCEDURE WITH A LOW COMPLICATION RATE. IN A MULTICENTER PROSPECTIVE STUDY OF 20,986 BRONCHOSCOPIES THE TOTAL NUMBER OF ANY COMPLICATIONS WAS REPORTED TO BE 227 (1.08%) INCLUDING 5 ARRHYTHMIAS (0.02%) AND 4 TOTAL DEATHS (0.02%). A MULTICENTER STUDY REPORTED 13 (2.2%) COMPLICATIONS WITH NO ARRHYTHMIAS NOR DEATHS ASSOCIATED WITH 581 CASES. A PROSPECTIVE MULTICENTER INTERNATIONAL STUDY OF 1,215 REPORTED 1 ASSOCIATED DEATH (0.08%) AND NO ARRHYTHMIAS. ANOTHER SURVEY-BASED STUDY OF 103,978 BRONCHOSCOPIES DESCRIBED 71 CASES (0.068%) OF ANY ASSOCIATED CARDIOVASCULAR EVENTS. A RECENT META-ANALYSIS OF NAVIGATIONAL BRONCHOSCOPY IN 10,381 PATIENTS REPORTED AN OVERALL ADVERSE EVENT RATE OF 5.6% INCLUDING A RATE OF 0.02% OF ANY ARRHYTHMIA AND 1 DEATH. A CASE SERIES OF ION ROBOTIC ASSISTED BRONCHOSCOPIES PUBLISHED AFTER THE META-ANALYSIS INCLUDING 415 CASES REPORTED NO CARDIAC EVENTS. THERE IS NO ALLEGATION THAT A MALFUNCTION OF THE ION SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. GIVEN THE AVAILABLE DATA THE EVENT WAS LIKELY DUE TO THE PROCEDURE UNDER GENERAL ANESTHESIA AND NOT ASSOCIATED WITH ION SYSTEM, INSTRUMENTS, OR ACCESSORIES. 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. 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. 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 EXPERIENCED VENTRICULAR TACHYCARDIA (VT). THE LESION SCHEDULED FOR BIOPSY WAS 1 CM IN SIZE AND LOCATED IN THE LEFT UPPER LOBE WITHIN 1 CM FROM THE PLEURA. IT WAS REPORTED THAT THE PATIENT WAS VERY SICK AND WAS ALSO DIAGNOSED WITH AIDS. THE PATIENT EXPERIENCED VT AND THE PROCEDURE WAS ABORTED DUE TO CONCERN FROM THE ANESTHESIA TEAM REGARDING THE CARDIAC ARRYTHMIA, IN ORDER TO DO CARDIAC WORK UP. THE ION SYSTEM WAS UNDOCKED FROM THE PATIENT AND NO BIOPSIES WERE OBTAINED. THE PHYSICIAN BELIEVED THE CAUSE OF THE VT WAS UNCLEAR, BUT WAS ANESTHESIA RELATED. THE PATIENT WAS ADMITTED TO THE INTENSIVE CARE UNIT FOR MONITORING FOR 1 DAY THEN DISCHARGED HOME. PER THE PHYSICIAN, THERE WAS NO ALLEGATION THAT A MALFUNCTION OF AN ION SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED, AND THE PHYSICIAN BELIEVES THE EVENT IS NOT RELATED TO THE ION PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1178304 ION SYSTEM CART EOQ INTUITIVE SURGICAL, INC 380748-61 N/A 00886874116234

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Life Threatening| H| R ION ENDOLUMINAL SYSTEM.