BEUDAMED
    FDA Adverse Event Death Summary report: N

    ION

    MDR report key: 19779995 · Received July 18, 2024

    Report

    Report Number
    2955842-2024-17260
    Event Type
    Death
    Date Received
    July 18, 2024
    Date of Event
    June 25, 2024
    Report Date
    June 25, 2024
    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
    AL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE ION SYSTEM LOGS FOR THE REPORTED PROCEDURE FOUND NO SYSTEM ERRORS OCCURRED DURING THE PROCEDURE THAT WERE RELEVANT TO THE REPORTED EVENT. DEVICE HISTORY RECORD (DHR) REVIEW FOR THE DEVICE(S) USED DURING THE REPORTED EVENT FOUND NO RELATED NON-CONFORMANCES. A REVIEW OF THE EVENT PERFORMED BY AN INTUITIVE SURGICAL MEDICAL SAFETY OFFICER (MSO) CONCLUDED THAT THE PATIENT UNDERWENT AN ION BIOPSY OF A RIGHT UPPER LOBE LESION. THE BIOPSY WAS COMPLETED AND MANUAL BRONCHOSCOPY WAS PERFORMED. BLEEDING WAS THEN OBSERVED AND EFFORTS TO CONTROL THE BLEEDING WERE UNSUCCESSFUL. THE PATIENT THEN CODED AND EFFORTS AT RESUSCITATION WERE ALSO UNSUCCESSFUL AND THE PATIENT DIED. THERE IS NO ALLEGATION OF MALFUNCTION OF THE ION SYSTEM, INSTRUMENTS OR ACCESSORIES. NO FURTHER DATA IS AVAILABLE DESPITE MULTIPLE ATTEMPTS TO OBTAIN FURTHER INFORMATION. BASED ON THE AVAILABLE DATA THE REPORTED ADVERSE EVENT WAS RELATED TO THE PROCEDURE. THERE IS NO COMPELLING EVIDENCE THAT THE EVENT WAS DEVICE RELATED. BRONCHOSCOPY IS A MINIMALLY INVASIVE PROCEDURE WITH A LOW RISK PROFILE. 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 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. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ION ENDOLUMINAL LUNG BIOPSY PROCEDURE, FOLLOWED BY STANDARD BRONCHOSCOPY. THE PATIENT EXPERIENCED UNCONTROLLED BLEEDING, CODED, AND EXPIRED. THE BIOPSY TARGET NODULE WAS 8 MILLIMETERS IN SIZE AND LOCATED IN THE RIGHT UPPER LOBE. THE BIOPSY WAS PERFORMED USING THE ION SYSTEM. AFTER THE ION BIOPSY PROCEDURE WAS COMPLETED, THE PHYSICIAN CHANGED TO A MANUAL BRONCHOSCOPE TO PERFORM A COMPLETE AIRWAY SURVEY WHEN THE BLEEDING WAS OBSERVED. THE BLEEDING COULD NOT BE CONTROLLED DESPITE UNSPECIFIED MEDICAL INTERVENTION. THE PATIENT'S CONDITION DETERIORATED, AND A CODE WAS CALLED. ADVANCED CARDIOPULMONARY LIFE SUPPORT WAS PERFORMED; HOWEVER, RESUSCITATION WAS UNSUCCESSFUL AND THE PATIENT EXPIRED. THERE WAS NO REPORT OF ANY DEVICE ISSUES ASSOCIATED WITH THE EVENT. MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WERE MADE; HOWEVER, NO FURTHER DETAILS HAVE BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2032213 ION SYSTEM CART EOQ INTUITIVE SURGICAL, INC 380748-60 N/A 00886874116234

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female Required Intervention| D ION ENDOLUMINAL SYSTEM