BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ION

    MDR report key: 20412128 · Received October 9, 2024

    Report

    Report Number
    2955842-2024-19872
    Event Type
    Injury
    Date Received
    October 9, 2024
    Date of Event
    September 17, 2024
    Report Date
    September 17, 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
    UT, 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: A PATIENT IN THEIR 70S UNDERWENT AN ION BRONCHOSCOPY TO BIOPSY AS LUNG LESION. DURING THE PROCEDURE ECG CHANGES INCLUDING ST ELEVATION AND BRADYCARDIA WAS NOTED. THESE WERE TRANSIENT, RESOLVED SPONTANEOUSLY AND REQUIRED NO SPECIFIC INTERVENTION. THE PROCEDURE WAS ABORTED AND BIOPSIES WERE NOT OBTAINED. THE PATIENT UNDERWENT EMERGENT LEFT HEARTH CATHETERIZATION WHICH REVEALED NO SIGNIFICANT OBSTRUCTIVE CORONARY ARTERY DISEASE. THE EVENTS WERE ATTRIBUTED TO POSSIBLE VASOSPASM. THE PATIENT WAS MONITORED FOR <24 HOURS AND DISCHARGED HOME WITHOUT FURTHER CONSEQUENCE. THERE WAS NO MALFUNCTION OF THE ION SYSTEM, INSTRUMENTS OR ACCESSORIES. BASED ON THE AVAILABLE DATA THE ECG CHANGES WERE PROCEDURE RELATED AND NOT DEVICE RELATED. BRONCHOSCOPY AND BIOPSY IS A MINIMALLY INVASIVE PROCEDURE WITH A LOW COMPLICATION RATE. IN A MULTICENTER PROSPECTIVE STUDY OF 20,986 BRONCHOSCOPIES THE TOTAL NUMBER OF ANY COMPLICATIONS WAS REPORTED TO BE 227 (1.08%) INCLUDING 5 ARRHYTHMIAS (0.02%) AND 4 TOTAL DEATHS (0.02%). A MULTICENTER STUDY REPORTED 13 (2.2%) COMPLICATIONS WITH NO ARRHYTHMIAS NOR DEATHS ASSOCIATED WITH 581 CASES. A PROSPECTIVE MULTICENTER INTERNATIONAL STUDY OF 1,215 REPORTED 1 ASSOCIATED DEATH (0.08%) AND NO ARRHYTHMIAS. ANOTHER SURVEY-BASED STUDY OF 103,978 BRONCHOSCOPIES DESCRIBED 71 CASES (0.068%) OF ANY ASSOCIATED CARDIOVASCULAR EVENTS. 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. A 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. OST DE, ERNST A, LEI X, ET AL. DIAGNOSTIC YIELD AND COMPLICATIONS OF BRONCHOSCOPY FOR PERIPHERAL LUNG LESIONS. RESULTS OF THE AQUIRE REGISTRY. AM J RESPIR CRIT CARE MED. 2016. 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 THE PATIENT UNDERWENT AN ION ENDOLUMINAL LUNG BIOPSY PROCEDURE AND EXPERIENCED S-T ELEVATION AND BRADYCARDIA THAT DID NOT REQUIRE MEDICAL INTERVENTION. THE PATIENT DID NOT HAVE A CARDIOVASCULAR HISTORY. PER THE PHYSICIAN, DURING THE SECOND BIOPSY PASS, THE PATIENT BECAME BRADYCARDIC WITH S-T ELEVATIONS; THEREFORE, THE PROCEDURE WAS ABORTED AND NO FURTHER BIOPSIES WERE OBTAINED. THE PHYSICIAN SPECULATED THAT THE PATIENT MAY HAVE EXPERIENCED A VASOSPASM OR POSSIBLE ACUTE MYOCARDIAL INFARCTION (MI). THE PATIENT WAS STABILIZED (NO CPR REQUIRED) AND SENT TO THE CATHETERIZATION LAB, WHERE THE CATHETERIZATION WAS NORMAL WITH CLEAN VESSELS. ADDITIONALLY, INITIAL IMAGING WAS NEGATIVE FOR A PNEUMOTHORAX OR SIGNIFICANT BLEEDING. THE PATIENT WAS NOT PROVIDED WITH ANY MEDICATIONS AND WAS MONITORED FOR LESS THAN 24 HOURS THEN DISCHARGED HOME. A FOLLOW-UP BIOPSY WAS EXPECTED. THERE WAS NO ALLEGATION THAT A MALFUNCTION OF AN ION SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1714904 ION SYSTEM CART EOQ INTUITIVE SURGICAL, INC 380748-60 UNKNOWN 00886874116234

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention ION ENDOLUMINAL SYSTEM.