BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ION

    MDR report key: 18715067 · Received February 15, 2024

    Report

    Report Number
    2955842-2024-11107
    Event Type
    Injury
    Date Received
    February 15, 2024
    Date of Event
    January 19, 2024
    Report Date
    January 19, 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
    NJ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A SYSTEM LOG REVIEW CANNOT BE PERFORMED BECAUSE THE SYSTEM LOGS ARE NOT AVAILABLE. A REVIEW OF THE EVENT WAS CONDUCTED BY AN INTUITIVE SURGICAL, INC. (ISI) MEDICAL SAFETY OFFICER AND THE FOLLOWING ADDITIONAL INFORMATION WAS PROVIDED: "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. THERE WAS NO ALLEGATION OF A MALFUNCTION OF THE ION SYSTEM, INSTRUMENT OR ACCESSORIES ASSOCIATED WITH THE REPORTED COMPLICATION. BASED ON THE AVAILABLE DATA THE EVENT WAS PROCEDURE RELATED INCLUDING ANESTHESIA IN A PATIENT WITH A SIGNIFICANT CARDIOMYOPATHY SUPERIMPOSED ON OTHER COMORBIDITIES INCLUDING COPD, AML AND RECENT COVID INFECTION AND WAS NOT DEVICE RELATED. 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 CODED. CARDIAC CLEARANCE SHOWED THE PATIENT TO BE HIGH RISK AFTER AN ECHO REVEALED LOW EJECTION FRACTION. THE PATIENT HAD PRE-EXISTING COPD, HEART FAILURE, RELAPSING ACUTE MYELOID LEUKEMIA AND COVID. THE PHYSICIAN WAS ABLE TO BIOPSY 2 LESIONS (LEFT UPPER LOBE AND RIGHT LUNG) AND AFTER UNDOCKING ION, STAGING (USING LINEAR EBUS) WAS COMPLETED WITHOUT ANY PRODUCT ISSUE. SOON AFTER THE ION PROCEDURE WAS COMPLETED, THE PATIENT EXPERIENCED A CARDIAC ARREST AND A FULL CODE WAS CALLED THAT LASTED 3 MINUTES WITH 1 ROUND OF CPR. WHILE STILL INTUBATED, THE PATIENT WAS TRANSFERRED TO THE ICU. THE PHYSICIAN BELIEVED AN ION PRODUCT DID NOT CAUSE OR CONTRIBUTE TO THE CODE AND THAT THIS WOULD HAVE OCCURRED WITH ANOTHER BIOPSY MODALITY. LATER, THE PATIENT WAS FOUND TO BE SEPTIC AND HAD A RECENT COVID INFECTION. IT IS UNCLEAR IF THE CUSTOMER WAS AWARE OF THE RECENT COVID INFECTION PRIOR THE PROCEDURE. THE PATIENT WAS HOSPITALIZED FOR 1 WEEK AND WAS DISCHARGED TO HOSPICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2379145 ION SYSTEM CART EOQ INTUITIVE SURGICAL, INC 380748-42 UNKNOWN 00886874116234

    Patients

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