BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ION

    MDR report key: 24075292 · Received January 14, 2026

    Report

    Report Number
    2955842-2026-01410
    Event Type
    Injury
    Date Received
    January 14, 2026
    Date of Event
    December 1, 2025
    Report Date
    January 14, 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
    AZ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE EVENT WAS CONDUCTED BY AN INTUITIVE SURGICAL, INC. (ISI) MEDICAL OFFICER AND THE FOLLOWING ADDITIONAL INFORMATION WAS PROVIDED: "A PATIENT IN THEIR 50S UNDERWENT AN ION LUNG BIOPSY OF RIGHT UPPER LOBE TARGET. 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. 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 (B)(4) 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." 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. 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. .

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN ION PROCEDURE (AFTER DOCKING) THE PATIENT EXPERIENCED A CARDIAC ARRHYTHMIA THAT REQUIRED DEFIBRILLATION. THE BIOPSIED LESION WAS IN THE RIGHT UPPER LOBE AND 8 MM IN SIZE. THE PATIENT HAD A MEDICAL HISTORY OF PULMONARY HYPERTENSION AND NO HISTORY OF SMOKING. DURING THE PROCEDURE, THE PATIENT EXPERIENCED VENTRICULAR FIBRILLATION. THE PHYSICIAN WAS NOT SURE WHAT CAUSE THE VENTRICULAR FIBRILLATION, BUT THOUGHT THE EVENT MAY HAVE OCCURRED DUE TO PULMONARY HYPERTENSION. MEDICAL INTERVENTIONS INCLUDED CARDIAC MASSAGE AND DEFIBRILLATION. THE PROCEDURE WAS ABORTED DUE TO THE ARRHYTHMIA. THE PATIENT WAS REVIVED, THEN SENT TO THE INTENSIVE CARE UNIT (ICU) FOR 1 DAY AND SPENT A FEW MORE DAYS HOSPITALIZED OUTSIDE OF THE ICU. THE PATIENT WAS DISCHARGED HOME IN STABLE CONDITION. THERE WAS NO ALLEGATION THAT A MALFUNCTION OF AN ION SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136218 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