BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ION

    MDR report key: 24179368 · Received January 26, 2026

    Report

    Report Number
    2955842-2026-01389
    Event Type
    Injury
    Date Received
    January 26, 2026
    Date of Event
    December 26, 2025
    Report Date
    January 26, 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
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS ADVERSE EVENT. THERE IS NO INDICATION THAT THE CUSTOMER REPORTED COMPLICATION WAS RELATED TO A PRODUCT ISSUE. THERE WAS NO ALLEGATION THAT A MALFUNCTION OF AN ION SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED DURING THE PROCEDURE BASED ON THE REVIEWED CLINICAL FEEDBACK. AN ION PRODUCT WAS NOT RETURNED TO INTUITIVE SURGICAL, INC. (ISI) FOR EVALUATION. SYSTEM LOGS ARE NOT AVAILABLE FOR REVIEW. AN ISI MEDICAL SAFETY OFFICER (MSO) REVIEWED THE INFORMATION AND PROVIDED THE FOLLOWING: "A 77-YEAR-OLD PATIENT UNDERWENT AN ION LUNG BIOPSY. AFTER BIOPSIES WERE OBTAINED, INCLUDING CRYOBIOPSY AND BAL BLEEDING WAS NOTED. THE ION SYSTEM WAS REMOVED AND TRANSITIONED TO MANUAL BRONCHOSCOPY WHICH WAS WEDGED INTO THE RIGHT MIDDLE LOBE AT THE PRESUMED SITE OF BLEEDING AND COLD SALINE WAS INSTILLED. ATTEMPT AT LEFT MAIN STEM INTUBATION FOR LUNG ISOLATION WAS UNSUCCESSFUL AS THE MAIN CARINA WAS NOT ABLE TO BE VISUALIZED. PEA ARREST WAS NOTED FOR WHICH RESUSCITATION EFFORTS, INCLUDING 1 MG OF EPINEPHRINE AND ONE ROUND OF CPR WAS ADMINISTERED WITH SUCCESSFUL RETURN OF SPONTANEOUS CIRCULATION. 1 MG OF EPINEPHRINE AND 500 MG OF TRANEXAMIC ACID WAS ADMINISTERED DOWN THE ENDOTRACHEAL TUBE. THE BLEEDING STOPPED AND SATURATIONS IMPROVED. PAST HISTORY WAS NOTABLE FOR CORONARY DISEASE AND A DRUG ELUDING STENT WAS PLACED NINE MONTHS PRIOR FOR WHAT THE PATIENT WAS ON PLAVIX. THE PATIENT IS REPORTED AS CURRENTLY BEING STABLE AND AWAITING DISCHARGE TO A REHABILITATION FACILITY. THERE WAS NO ALLEGATION OF MALFUNCTION OF THE ION SYSTEM, INSTRUMENTS OR 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 FOR SIGNIFICANT BLEEDING. A RETROSPECTIVE STUDY OF 20,986 BRONCHOSCOPIES REPORTED 21 EPISODES OF HEMOPTYSIS OF > 50 ML (0.38%) AND 19 EPISODES < 50 ML (0.34%). A PROSPECTIVE MULTICENTER INTERNATIONAL STUDY OF 1,215 NAVIGATIONAL BRONCHOSCOPY CASES REPORTED A BLEEDING RATE OF 2.5% OVERALL AND A CTCAE GRADE 2 OR GREATER BLEEDING RATE OF 1.5%. A SINGLE CENTER RETROSPECTIVE REVIEW OF 19,017 BRONCHOSCOPIC BIOPSIES REPORTED A SEVERE BLEEDING RATE OF 0.79% WITH A HIGHER RATE IN MORE CENTRAL LESIONS. ANOTHER LARGE CASE SERIES OF 26,895 BRONCHOSCOPIES WITH BIOPSIES OF ANY TYPE REPORTED ANY BLEEDING IN 41.4% OF CASES BUT A SEVERE BLEEDING RATE OF 1.47%. A RECENT META-ANALYSIS OF NAVIGATIONAL BRONCHOSCOPY IN 10,381 PATIENTS REPORTED AN OVERALL ADVERSE EVENT RATE OF 5.6% WITH 1 DEATH. BLEEDING OF ANY SEVERITY WAS REPORTED IN 2.1% OF ALL CASES. THESE DATA REFLECT VARIOUS DEFINITIONS OF ANY BLEEDING IN THE LITERATURE RANGING FROM 0.72-41.4% WITH POSSIBLY MORE CONSISTENT DEFINITIONS OF MORE SEVERE CLINICALLY SIGNIFICANT BLEEDING RANGING FROM 0.38-1.47%. THE RATE OF DEATHS ASSOCIATED WITH BLEEDING WOULD BE SOME FRACTION OF THE REPORTED BLEEDING RATES AND WILL THUS BE MORE RARE THAN SIGNIFICANT BLEEDING. A RETROSPECTIVE STUDY OF 20,986 BRONCHOSCOPIES REPORTED 4 TOTAL DEATHS (0.02%). ANOTHER PROSPECTIVE MULTICENTER INTERNATIONAL STUDY OF 1,215 REPORTED 1 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 (0.01%). 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. BO L, SHI L, JIN F, LI C. THE HEMORRHAGE RISK OF PATIENTS UNDERGOING BRONCHOSCOPIC EXAMINATIONS OR TREATMENTS. AM J TRANSL RES. 2021. 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 ENDOBRONCHIAL LUNG BIOPSY PROCEDURE, THE PATIENT CODED AND SURVIVED. INTUITIVE SURGICAL INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: AFTER CRYOBIOPSY AND BRONCHOALVEOLAR LAVAGE (BAL), THE PATIENT EXPERIENCED A PULMONARY HEMORRHAGE FROM THE SITE OF THE BIOPSY WHICH EVENTUALLY RESULTED IN CARDIAC ARREST. THE ION SYSTEM WAS REMOVED, AND A REGULAR BRONCHOSCOPE WAS PUT IN; A BLIND WEDGE WAS DONE AT THE PRESUMED SITE OF BLEEDING. COLD SALINE WAS INSTILLED, BUT PROFUSE BLEEDING PERSISTED. THE PATIENT DESATURATED AND HAD A PULSELESS ELECTRICAL ACTIVITY (PEA) ARREST WITH RETURN OF SPONTANEOUS CIRCULATION (ROSC) AFTER 1MG EPINEPHRINE (EPI) AND 1 ROUND OF CARDIOPULMONARY RESUSCITATION (CPR). THE BLEEDING CONTINUED AND 1MG OF EPI AND 500MG TRANEXAMIC ACID WAS GIVEN DOWN THE ENDOTRACHEAL TUBE (ETT). AFTER THESE INTERVENTIONS, THE BLEEDING STOPPED AND SATURATIONS IMPROVED. LAB TESTS WERE PERFORMED. THE PHYSICIAN STATES THAT THE CAUSE OF THE CARDIAC ARREST WAS PULMONARY HEMORRHAGE. THE PATIENT HAS A HISTORY OF CORONARY ARTERY DISEASE WITH A HISTORY OF DRUG ELUTING STENT NINE MONTHS AGO. PER THE PHYSICIAN, THE ION SYSTEM IS NOT SUSPECTED IN CONTRIBUTING TO THE EVENT. THE PHYSICIAN REPORTS THAT THE PATIENT HAS CORONARY ARTERY DISEASE ON PLAVIX. THE PATIENT'S CURRENT STATUS IS STABLE, AND THEY ARE AWAITING DISCHARGE TO A REHAB FACILITY AT THE TIME OF THE REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244175 ION SYSTEM CART EOQ INTUITIVE SURGICAL, INC 380748-60 N/A 00886874116234

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male Hospitalization| L| R ION ENDOLUMINAL SYSTEM.