BEUDAMED
    FDA Adverse Event Death Summary report: N

    ION

    MDR report key: 22163945 · Received June 7, 2025

    Report

    Report Number
    2955842-2025-24301
    Event Type
    Death
    Date Received
    June 7, 2025
    Date of Event
    May 14, 2025
    Report Date
    May 14, 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
    MN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SYSTEM LOGS ARE NOT AVAILABLE FOR REVIEW. A DEVICE HISTORY RECORD (DHR) REVIEW FOUND NO NON-CONFORMANCES THAT WOULD BE RELATED TO THE REPORTED EVENT. A REVIEW OF THE EVENT PERFORMED BY AN INTUITIVE SURGICAL MEDICAL SAFETY OFFICER (MSO) CONCLUDED THAT A PATIENT UNDERWENT AN ION LUNG BIOPSY. THE PROCEDURE WAS COMPLETED WITHOUT ISSUE AND THE ION SYSTEM WAS UNDOCKED. THE PATIENT THEN CODED AND EFFORTS AT RESUSCITATION WERE UNSUCCESSFUL. EFFORTS AT OBTAINING FURTHER DATA HAVE BEEN UNSUCCESSFUL. BASED ON THE AVAILABLE DATA THE EVENTS WERE POSSIBLY PROCEDURE RELATED. THERE WAS NO REPORTED MALFUNCTION OF THE ION SYSTEM, INSTRUMENTS OR ACCESSORIES. 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. SECTION A2 PATIENT AGE: THE PATIENT'S AGE WAS REPORTED AS IN THEIR "EARLY 80'S" YRS.

    Additional Manufacturer Narrative · 0

    SECTION B5: ADDITIONAL INFORMATION - THE ENDOLUMINAL SALES REPRESENTATIVE RECEIVED ADDITIONAL INFORMATION THAT THE LUNG LESION SIZE WAS UNDER 3 CM AND THERE WERE NO ISSUES WITH THE ION SYSTEM DURING THE PROCEDURE. THE PATIENT HAD A KNOWN CARDIAC HISTORY, WAS INFORMED OF THE RISKS PRIOR TO THE ION PROCEDURE, AND OPTED TO PROCEED WITH THE LUNG BIOPSY. CARDIOPULMONARY RESUSCITATION WAS INITIATED FOR THE CARDIAC ARREST AND WAS PERFORMED FOR 30 MINUTES. THE PATIENT MAY HAVE DIED FROM A CARDIAC RELATED EVENT. NO OTHER INFORMATION WAS AVAILABLE. A RE-REVIEW OF THE EVENT PERFORMED BY AN INTUITIVE SURGICAL MEDICAL SAFETY OFFICER (MSO) UPON RECEIPT OF ADDITIONAL INFORMATION CONCLUDED THAT THE PATIENT HAD A PRIOR UNSPECIFIED CARDIOVASCULAR HISTORY BUT DECIDED TO UNDERGO AN ION LUNG BIOPSY AFTER DISCUSSING THE POTENTIAL RISK INVOLVED. THE PROCEDURE WAS COMPLETED WITHOUT ISSUE AND THE ION SYSTEM WAS UNDOCKED. THE PATIENT THEN CODED AND EFFORTS AT RESUSCITATION INCLUDING CPR FOR 30 MINUTES WERE UNSUCCESSFUL. THERE WAS NO REPORTED MALFUNCTION OF THE ION SYSTEM, INSTRUMENTS OR ACCESSORIES. BASED ON THE AVAILABLE DATA THE EVENT WAS POSSIBLY PROCEDURE RELATED IN THE SETTING OF KNOWN PRIOR CARDIOVASCULAR HISTORY. 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 THE ION SYSTEM, INSTRUMENTS, OR ACCESSORIES. BRONCHOSCOPY IS A MINIMALLY INVASIVE PROCEDURE WITH A LOW RISK PROFILE. A RETROSPECTIVE STUDY OF 20,986 BRONCHOSCOPIES REPORTED 4 ASSOCIATED DEATHS (0.02%), 5 ARRHYTHMIAS (0.02%) AND 1 MYOCARDIAL INFARCTION (0.004%). ONE PROSPECTIVE MULTICENTER INTERNATIONAL STUDY OF 1,215 REPORTED 1 ASSOCIATED DEATH (0.08%) AND NO ASSOCIATED EVENTS OF MYOCARDIAL INFARCTION OR ARRHYTHMIAS. 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. ANOTHER 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 AFTER AN ION ENDOLUMINAL LUNG BIOPSY PROCEDURE THE PATIENT DIED. THE BIOPSIED LESION WAS LOCATED IN THE RIGHT UPPER LOBE. AFTER UNDOCKING THE ION SYSTEM THE PATIENT CODED. CARDIOPULMONARY RESUSCITATION WAS INITIATED BUT WAS UNSUCCESSFUL. THERE WAS NO REPORT OF ANY ISSUES DURING THE PROCEDURE, AND NO MALFUNCTION OF AN ION SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION FROM THE PHYSICIAN, NO RESPONSE HAS BEEN RECEIVED.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION. ADDITIONAL INFORMATION CAN BE FOUND IN THE FOLLOWING FIELDS: H11 AND B7.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    719047 ION SYSTEM CART EOQ INTUITIVE SURGICAL, INC 380748-61 N/A 00886874116234

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Male Death DA VINCI INSTRUMENTS AND ACCESSORIES