BEUDAMED
    FDA Adverse Event Death Summary report: N

    ION

    MDR report key: 22379526 · Received July 1, 2025

    Report

    Report Number
    2955842-2025-27960
    Event Type
    Death
    Date Received
    July 1, 2025
    Date of Event
    June 4, 2025
    Report Date
    June 4, 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
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SYSTEM LOGS ARE NOT AVAILABLE FOR REVIEW. A REVIEW OF THE EVENT PERFORMED BY AN INTUITIVE SURGICAL MEDICAL SAFETY OFFICER (MSO) CONCLUDED THAT A PATIENT OF UNKNOWN AGE UNDERWENT AN ION LUNG BIOPSY FROM A LESION LOCATED IN THE LEFT UPPER LOBE. THE PATIENT CODED AND ULTIMATELY DIED. THERE WAS NO REPORTED MALFUNCTION OF THE ION SYSTEM, INSTRUMENTS OR ACCESSORIES. BASED ON THE AVAILABLE DATA THE DEATH WAS POSSIBLY PROCEDURE RELATED BUT NOT DEVICE RELATED. ATTEMPTS AT OBTAINING FURTHER DATA HAVE BEEN UNSUCCESSFUL. BRONCHOSCOPY IS A MINIMALLY INVASIVE PROCEDURE WITH A LOW RISK PROFILE. A RETROSPECTIVE STUDY OF 20,986 BRONCHOSCOPIES REPORTED 4 ASSOCIATED DEATHS (0.02%). ANOTHER PROSPECTIVE MULTICENTER INTERNATIONAL STUDY OF 1,215 REPORTED 1 ASSOCIATED 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. 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 --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 A PATIENT CODED DURING AN ION TRANSBRONCHIAL LUNG BIOPSY OF THE OF THE LEFT UPPER LOBE (LUL). THE PROCEDURE WAS ABORTED. THE PHYSICIAN INFORMED THE INTUITIVE ENDOLUMINAL TERRITORY ASSOCIATE (ETA) AFTER THE CASE THAT THE PATIENT DID NOT RECOVER AND SUBSEQUENTLY PASSED AWAY. NO ADDITIONAL INFORMATION WAS PROVIDED; THERE WAS NO REPORT OF ANY MALFUNCTIONS WITH THE ION SYSTEM OR ANY INSTRUMENTS AND ACCESSORIES. A REVIEW OF THE PROCEDURE VIDEO ON SITE BY THE ETA FOUND NO ISSUES OR MALFUNCTIONS OF THE ION SYSTEM DURING THE PROCEDURE. MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION FROM THE PHYSICIAN HAVE BEEN MADE; HOWEVER, NO NEW INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1143022 ION SYSTEM CART EOQ INTUITIVE SURGICAL, INC 380748-60 N/A 00886874116234

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Death ION ENDOLUMINAL SYSTEM