BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ION

    MDR report key: 20988013 · Received December 20, 2024

    Report

    Report Number
    2955842-2024-23497
    Event Type
    Injury
    Date Received
    December 20, 2024
    Date of Event
    November 27, 2024
    Report Date
    November 27, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    EOQ
    PMA / PMN Number
    K182188
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF THE BLEEDING CANNOT BE DETERMINED. THERE WAS NO ALLEGATION THAT A MALFUNCTION OF AN ION SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED DURING THE PROCEDURE SYSTEM LOGS WERE NOT AVAILABLE FOR REVIEW. A REVIEW OF THE EVENT WAS CONDUCTED BY AN INTUITIVE SURGICAL, INC. (ISI) MEDICAL OFFICER AND THE FOLLOWING ADDITIONAL INFORMATION WAS PROVIDED: A 51-YEAR-OLD PATIENT UNDERWENT AN ION LUNG BIOPSY COMPLICATED BY BLEEDING. BIOPSIES WERE COMPLETED THEN BLEEDING WAS NOTED AFTER BAL. HEMOSTASIS WAS ACHIEVED AND THE PATIENT WAS ADMITTED TO THE ICU INTUBATED. LATER THE SAME DAY THE AIRWAYS WERE CLEARED WITH REPEAT BRONCHOSCOPY CONFIRMING HEMOSTASIS. THE PATIENT WAS EXTUBATED AND DISCHARGED IN LESS THAN 24 HOURS. BASED ON THE AVAILABLE DATA THE ADVERSE EVENT WAS PROCEDURE-RELATED AND NOT 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 OF < 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 SINGLE-CENTER RETROSPECTIVE REVIEW OF 19,017 BRONCHOSCOPIC BIOPSIES REPORTED A SEVERE BLEEDING RATE OF 0.79% WITH A HIGHER RATE IN MORE CENTRAL LESIONS. 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 AFTER AN ION-ASSISTED ENDOLUMINAL LUNG BIOPSY PROCEDURE, THE PATIENT EXPERIENCED BLEEDING REQUIRING MEDICAL INTERVENTION. THE 1-CENTIMETER TARGET NODULE WAS IN THE LEFT LOWER LOBE NEAR THE PLEURA AND A BLOOD VESSEL AND WAS DESCRIBED AS FRIABLE MUCOSA. DESPITE THIS, THE ION PORTION OF THE PROCEDURE WAS COMPLETED AS PLANNED, AND BIOPSY SAMPLES WERE OBTAINED FOR DIAGNOSIS. THE BLEEDING OCCURRED DURING BRONCHOALVEOLAR LAVAGE (BAL) WHILE THE PHYSICIAN PERFORMED AN AIRWAY SURVEY. TO CONTROL THE BLEEDING, COLD SALINE AND EPINEPHRINE INJECTIONS WERE ADMINISTERED, AND SELECTIVE INTUBATION OF THE RIGHT LUNG WAS PERFORMED. THE PATIENT WAS THEN SENT TO THE INTENSIVE CARE UNIT (ICU). AFTER 6-7 HOURS OF SELECTIVE INTUBATION, A REDO BRONCHOSCOPY AND BAL WERE PERFORMED TO CLEAR THE LEFT LUNG. THE ESTIMATED TOTAL BLOOD LOSS WAS 50 CC, AND NO BLOOD TRANSFUSION WAS NEEDED. THE PATIENT WAS HOSPITALIZED FOR LESS THAN 24 HOURS BEFORE BEING DISCHARGED HOME. THE PHYSICIAN REPORTED THAT THE BLEEDING WAS AN EXPECTED COMPLICATION OF THE PROCEDURE, UNRELATED TO THE ION SYSTEM, AND THERE WAS NO DEVICE MALFUNCTION ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2168843 ION SYSTEM CART EOQ INTUITIVE SURGICAL, INC 380748-65 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Male Required Intervention DA VINCI INSTRUMENTS AND ACCESSORIES