BEUDAMED
    FDA Adverse Event Death Summary report: N

    ION

    MDR report key: 18619001 · Received January 31, 2024

    Report

    Report Number
    2955842-2024-10827
    Event Type
    Death
    Date Received
    January 31, 2024
    Date of Event
    December 14, 2023
    Report Date
    January 3, 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
    MA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE SHOWED THERE WERE NO RELATED SYSTEM ERRORS TO HAVE OCCURRED DURING THE PROCEDURE THAT WOULD HAVE LIKELY CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. A REVIEW OF THE EVENT WAS CONDUCTED BY AN INTUITIVE SURGICAL MEDICAL OFFICER WHO CONCLUDED THAT BASED ON THE AVAILABLE DATA, THE PATIENT DEATH WAS RELATED TO UNDERLYING MEDICAL COMORBIDITIES LEADING TO THE PATIENT BEING PLACED ON HOSPICE AND WAS NOT RELATED TO THE PROCEDURE OR ION SYSTEM, INSTRUMENTS OR ACCESSORIES. THERE WERE NO PROCEDURE RELATED COMPLICATIONS REPORTED AND THERE WAS NO ALLEGATION THAT A MALFUNCTION OF AN ION SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. 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.

    Additional Manufacturer Narrative · 0

    SECTION B5 UPDATES: THE CAUSE OF DEATH WAS RESPIRATORY FAILURE. HOSPITAL LENGTH OF STAY: 1 WEEK ONLY COMFORT MEASURES WERE PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ION ENDOLUMINAL LUNG BIOPSY PROCEDURE AND EXPERIENCED AN UNSPECIFIED RESPIRATORY ISSUE AND EXPIRED ON AN UNSPECIFIED DATE. THE BIOPSIED LESION WAS 6CM IN SIZE AND LOCATED IN THE RIGHT LOWER LOBE. RADIAL EBUS WAS UTILIZED TO LOCALIZE THE LESION. TOOLS USED DURING BIOPSY UNDER C-ARM FLUOROSCOPY INCLUDED A 21G FLEXISION NEEDLE, A 23G FLEXISION NEEDLE, A CYTOLOGY BRUSH, AND A BRONCHOALVEOLAR LAVAGE WAS ALSO PERFORMED. THE DIAGNOSIS OBTAINED FROM PATHOLOGY WAS ADENOCARCINOMA (MALIGNANT). THERE WERE NO PROCEDURE RELATED COMPLICATIONS REPORTED. THERE IS NO ALLEGATION THAT A MALFUNCTION OF AN ION SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. INTUITIVE SURGICAL HAS MADE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, NO NEW INFORMATION HAS BEEN RECEIVED.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385619 ION SYSTEM CART EOQ INTUITIVE SURGICAL, INC 380748-61 UNKNOWN 00886874116234

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Female ION ENDOLUMINAL SYSTEM