BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ION

    MDR report key: 22376132 · Received July 1, 2025

    Report

    Report Number
    2955842-2025-27955
    Event Type
    Injury
    Date Received
    July 1, 2025
    Date of Event
    June 4, 2025
    Report Date
    June 4, 2025
    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
    NY, US
    Reporter Occupation
    003

    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 ISI MEDICAL SAFETY OFFICER (MSO) AND THE FOLLOWING ADDITIONAL INFORMATION WAS PROVIDED: "A 65-YEAR-OLD PATIENT UNDERWENT AN ION LUNG BIOPSY OF A LEFT LOWER LOBE LESION. THERE WAS MORE BLEEDING THAN EXPECTED. THE PATIENT DECOMPENSATED INTO ASYSTOLE. RESUSCITATION EFFORTS WERE SUCCESSFUL, AND THE PATIENT WAS TRANSFERRED TO THE ICU WHERE CARE WAS CONTINUED. ATTEMPTS AT OBTAINING FURTHER INFORMATION HAS BEEN UNSUCCESSFUL. THERE WAS NO REPORTED MALFUNCTION OF THE ION SYSTEM, INSTRUMENTS OR ACCESSORIES. BASED ON THE AVAILABLE DATA THE EVENT WAS LIKELY 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. 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. 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."

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B7, H2, H6, AND H11 ADDITIONAL INFORMATION: THE PATIENT IS A NON-HISPANIC CAUCASIAN WITH NO HISTORY OF SMOKING NOR LUNG DISEASE. THE PATIENT WAS NOT ON ANY ANTIPLATELETS/ANTICOAGULATION THERAPIES AND DID NOT HAVE ANY LUNG DISEASE OR SMOKING HISTORY. THE BIOPSIED LESION WAS PERIPHERAL AND LOCATED IN THE LEFT LOWER LOBE VERY CLOSE TO THE PLEURA AND WAS APPROXIMATELY 0.5 - 1.0 CM IN SIZE. THE BLEEDING OCCURRED AS THE CATHETER WAS BEING EXTRACTED FROM THE PERIPHERAL OF THE LUNG. AFTER THE ION ROBOT WAS UNDOCKED AND THE ENDOTRACHEAL TUBE WAS REMOVED, THE PATIENT CODED. A CODE WAS INITIATED AND IMPLEMENTED FOR 5 MINUTES. THE PATIENT WAS SUBSEQUENTLY ADMITTED TO THE INTENSIVE CARE UNIT (ICU). THE PHYSICIAN COULD NOT RECALL THE AMOUNT OF BLOOD LOSS (BL) BUT REPORTED THAT THE PATIENT REQUIRED AT LEAST 2 UNITS OF BLOOD AND WAS HOSPITALIZED FOR 2 WEEKS RELATED TO THE BLEEDING EVENT. THE PHYSICIAN DID NOT KNOW WHY THE BLEEDING OCCURRED. THE PHYSICIAN REPORTED IT WAS NOT NECESSARILY THE AMOUNT OF BL, BUT THE LOSS OF CONTROL OF THE AIRWAY DUE TO THE BLEEDING THAT WAS THE ISSUE. THE PROCEDURE WAS COMPLETED AND BIOPSIES WERE OBTAINED. THE DIAGNOSIS WAS UNDETERMINED - SOME INFLAMMATION, BUT NOTHING DEFINITIVE. THE PATIENT WILL BE RESCANNED AT A LATER DATE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER THE ION PORTION OF AN ENDOLUMINAL BIOPSY PROCEDURE, WHEN THE ION CATHETER HAD BEEN REMOVED, THE ION SYSTEM WAS UNDOCKED, AND THE MANUAL BRONCHOSCOPE WAS INSERTED, THERE WAS MORE BLOOD NOTED THAN EXPECTED. THE INTUITIVE SURGICAL, INC. (ISI) ENDOLUMINAL TERRITORY (ETA) WAS PRESENT DURING THE PROCEDURE AND REPORTED THAT THE PATIENT "FLATLINED A LITTLE BIT¿ AND THE PROCEDURAL TEAM CALLED A CODE "TO MAKE SURE THAT THEY HAD EXTRA HANDS-ON SITE." THE ETA EXITED THE ROOM DURING THE EVENT AND WAS LATER INFORMED THAT THE PATIENT WAS IN THE INTENSIVE CARE UNIT. THE BIOPSY SITE WAS IN A PERIPHERAL LESION VERY CLOSE TO THE PLEURA. THE FOLLOWING INFORMATION IS UNKNOWN: THE SOURCE AND CAUSE OF THE BLEEDING, THE ESTIMATED BLOOD LOSS VOLUME ASSOCIATED WITH THE BLEEDING, AND WHAT MEDICAL INTERVENTION (IF ANY) WAS RENDERED DUE TO THE COMPLICATIONS. THERE WAS NO ALLEGATION THAT A MALFUNCTION OF AN ION SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED, AND IT WAS UNKNOWN IF THE EVENT WAS RELATED TO THE ION PROCEDURE SINCE THE PHYSICIAN DID NOT KNOW WHAT HAPPENED. INTUITIVE SURGICAL INC. (ISI) HAS MADE MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, AS OF THE DATE OF THIS REPORT, NO NEW INFORMATION HAS BEEN OBTAINED.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1194142 ION SYSTEM CART EOQ INTUITIVE SURGICAL, INC 380748-65 UNKNOWN 00886874116234

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Female Hospitalization| R ION ENDOLUMINAL SYSTEM