BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ION

    MDR report key: 22766664 · Received August 9, 2025

    Report

    Report Number
    2955842-2025-33604
    Event Type
    Injury
    Date Received
    August 9, 2025
    Date of Event
    July 16, 2025
    Report Date
    July 16, 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

    THE SYSTEM LOGS ARE NOT AVAILABLE FOR REVIEW. A REVIEW OF THE EVENT INFORMATION PROVIDED WAS CONDUCTED BY AN INTUITIVE SURGICAL, INC. (ISI) MEDICAL SAFETY OFFICER (MSO) AND THE FOLLOWING ADDITIONAL INFORMATION WAS PROVIDED: A 64-YEAR-OLD PATIENT UNDERWENT AN ION BRONCHOSCOPY. DURING THE PROCEDURE, THE PATIENT WAS DIAGNOSED WITH AN ST ELEVATION. MYOCARDIAL INFARCTION AND THE PROCEDURE WAS ABORTED. LEFT HEART CATHETERIZATION CONFIRMED, SIGNIFICANT OBSTRUCTIVE, CORONARY DISEASE AND PERCUTANEOUS. CORONARY INTERVENTION WAS PERFORMED WITH STENT PLACEMENT IN THE RIGHT CORONARY ARTERY. THE PATIENT WAS HOSPITALIZED FOR TWO DAYS, THEN DISCHARGED HOME. THERE WAS NO REPORTED MALFUNCTION OF THE ION SYSTEM, INSTRUMENTS, NOR ACCESSORIES. 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%) AND 1 MYOCARDIAL INFARCTION (0.004%). A MORE RECENT PROSPECTIVE MULTICENTER INTERNATIONAL STUDY OF 1,215 REPORTED 1 ASSOCIATED DEATH (0.08%) AND NO ASSOCIATED EVENTS OF MYOCARDIAL INFARCTION. 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 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. 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 LUNG BIOPSY PROCEDURE, THE PATIENT BECAME UNSTABLE AND WAS DIAGNOSED WITH A ST ELEVATION MYOCARDIAL INFARCTION (STEMI), NECESSITATING HOSPITALIZATION. THE TARGET NODULE, MEASURING 1.5 CENTIMETERS, WAS LOCATED IN THE LEFT LOWER LOBE, LEADING TO THE PROCEDURE BEING ABORTED. THE PATIENT WAS REFERRED TO A CARDIOLOGIST AND TAKEN TO THE CARDIAC CATHETER LAB, WHERE IT WAS DISCOVERED THAT THE RIGHT CORONARY ARTERY (RCA) HAD 80-90% BLOCKAGE AND THE LEFT ANTERIOR DESCENDING ARTERY (LAD) HAD 60-70% LESIONS. A DRUG-ELUTING STENT WAS PLACED IN THE RCA. THE PATIENT WAS ADMITTED FOR TWO DAYS AND SUBSEQUENTLY DISCHARGED HOME. THE PHYSICIAN BELIEVED THE STEMI WAS NOT RELATED TO THE ION PROCEDURE AND ATTRIBUTED IT TO THE PATIENT'S PREEXISTING RISK FACTORS, SUCH AS AN EXTENSIVE SMOKING HISTORY AND HYPERTENSION. IT WAS CONSIDERED LIKELY THAT THE STEMI COULD HAVE OCCURRED THROUGH ANOTHER MODALITY. THERE WAS NO DEVICE MALFUNCTION ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    757288 ION SYSTEM CART EOQ INTUITIVE SURGICAL, INC 380748-65 N/A 00886874116234

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female Hospitalization| L| R ION ENDOLUMINAL SYSTEM