BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ION

    MDR report key: 20568322 · Received October 30, 2024

    Report

    Report Number
    2955842-2024-21367
    Event Type
    Injury
    Date Received
    October 30, 2024
    Date of Event
    October 1, 2024
    Report Date
    October 1, 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
    OH, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF BLEEDING CANNOT BE DETERMINED. SYSTEM LOGS WERE NOT AVAILABLE FOR REVIEW AT THIS TIME. A REVIEW OF THE EVENT WAS CONDUCTED BY AN INTUITIVE SURGICAL, INC. (ISI) MEDICAL SAFETY OFFICER AND THE FOLLOWING ADDITIONAL INFORMATION WAS PROVIDED: A 72-YEAR-OLD PATIENT WITH SIGNIFICANT CO-MORBIDITIES INCLUDING CIRRHOSIS WITH END STAGE LIVER DISEASE AND ASSOCIATED COAGULOPATHY, ESOPHAGEAL VARICES, ASCITES, RECURRENT GASTROINTESTINAL BLEEDING AND PANCREATIC CANCER WITH METASTASES UNDERWENT AN ION BIOPSY OF A RIGHT LOWER LOBE NODULE WITH A NEEDLE, BRUSH, FORCEPS AND CRYOPROBE. POST BIOPSY BLEEDING ESTIMATED TO BE 100 ML WAS NOTED INTRA-PROCEDURALLY IN SETTING OF END-STAGE LIVER DISEASE ASSOCIATED COAGULOPATHY. AN ENDOBRONCHIAL BLOCKER WAS PLACED AND THE PATIENT WAS ADMITTED TO THE ICU INTUBATED. 2 UNITS OF PRBC AND 2 UNITS OF FFP WERE TRANSFUSED. VITAMIN K WAS ADMINISTERED FOR COAGULOPATHY. HEMOSTASIS WAS ACHIEVED, THE BLOCKER WAS REMOVED AND THE PATIENT WAS EXTUBATED AND LIBERATED FROM MECHANICAL VENTILATION. THE PATIENT REMAINED HOSPITALIZED FOR A WEEK FOR RECURRENT GI BLEEDING WHICH WAS UNRELATED TO AIRWAY BLEEDING. WORK UP OF GI BLEEDING REVEALED PORTAL HYPERTENSIVE GASTROPATHY AS WELL AS A COLONIC LESION SUSPECTED TO BE MALIGNANT AND THE PATIENT WAS DISCHARGED HOME. THERE IS NO ALLEGATION THAT A MALFUNCTION OF THE ION SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. GIVEN THE AVAILABLE DATA THE REPORTED EVENT WAS PROCEDURE RELATED AND NOT DEVICE RELATED. BRONCHOSCOPY IS A MINIMALLY INVASIVE PROCEDURE WITH A LOW RISK PROFILE FOR SIGNIFICANT BLEEDING. 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 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. ANOTHER LARGE CASE SERIES OF 26,895 BRONCHOSCOPIES WITH BIOPSIES OF ANY TYPE REPORTED ANY BLEEDING IN 41.4% OF CASES BUT A SEVERE BLEEDING RATE OF 1.47%. 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. THESE DATA REFLECT VARIOUS DEFINITIONS OF ANY BLEEDING IN THE LITERATURE RANGING FROM 0.72-41.4% WITH POSSIBLY MORE CONSISTENT DEFINITIONS OF MORE SEVERE CLINICALLY SIGNIFICANT BLEEDING RANGING FROM 0.38-1.47%. 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. BO L, SHI L, JIN F, LI C. THE HEMORRHAGE RISK OF PATIENTS UNDERGOING BRONCHOSCOPIC EXAMINATIONS OR TREATMENTS. AM J TRANSL RES. 2021. 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 DURING AN ION ENDOLUMINAL LUNG BIOPSY PROCEDURE, THE PATIENT EXPERIENCED BLEEDING, REQUIRING UNPLANNED MEDICAL INTERVENTION AND HOSPITAL ADMISSION. THE PATIENT WAS KNOWN TO HAVE UNDERLYING COAGULOPATHY SECONDARY TO LIVER CIRRHOSIS. THE TARGET NODULE WAS 10X11X11 MILLIMETERS (MM) IN SIZE AND LOCATED IN THE RIGHT LOWER LOBE ANTERIOR SEGMENT 15 MM FROM THE PLEURA AND 5 MM FROM A MAJOR BLOOD VESSEL. THE BIOPSY TOOLS USED WERE A 21G FLEXISION NEEDLE, A THIRD-PARTY CYTOLOGY BRUSH, COMPATIBLE FORCEPS, AND A CRYOPROBE. THE BLEEDING OCCURRED DURING THE PROCEDURE, AND THE ESTIMATED BLOOD LOSS WAS 100 MILLILITERS. THE PHYSICIAN DEPLOYED AN ENDOBRONCHIAL BALLOON BLOCKER FOR TAMPONADE, KEPT THE PATIENT INTUBATED, AND TRANSFERRED HIM TO THE INTENSIVE CARE UNIT (ICU). THE PATIENT RECEIVED 2 UNITS OF PACKED RED BLOOD CELLS AND 2 UNITS OF FRESH FROZEN PLASMA. THE BALLOON BLOCKER WAS REMOVED THE NEXT DAY AND NO FURTHER BLEEDING WAS NOTED, SO THE PATIENT WAS EXTUBATED. THE PATIENT WAS HOSPITALIZED FOR A WEEK FOR REASONS UNRELATED TO THE AIRWAY BLEEDING. DURING ADMISSION, THE PATIENT RECEIVED VITAMIN K, 2 UNITS OF PACKED RED BLOOD CELLS, AND 2 UNITS OF FRESH FROZEN PLASMA. THE PATIENT HAD RECURRENT GASTROINTESTINAL BLEEDING (GIB) FROM A SLOW OOZE OF PORTAL HYPERTENSIVE GASTROPATHY. A COLONOSCOPY REVEALED A LIKELY MALIGNANT TUMOR. THE PATIENT WAS SUBSEQUENTLY DISCHARGED HOME. THE BLEEDING WAS AN ANTICIPATED COMPLICATION OF THE PROCEDURE, AND IT WOULD HAVE LIKELY OCCURRED VIA ANOTHER MODALITY. THERE WAS NO DEVICE MALFUNCTION ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    982183 ION SYSTEM CART EOQ INTUITIVE SURGICAL, INC 380748-44 N/A 00886874116234

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male Required Intervention| H DA VINCI INSTRUMENTS AND ACCESSORIES