BEUDAMED
    FDA Adverse Event Death Summary report: N

    ION

    MDR report key: 23796851 · Received December 12, 2025

    Report

    Report Number
    2955842-2025-48562
    Event Type
    Death
    Date Received
    December 12, 2025
    Date of Event
    November 20, 2025
    Report Date
    December 18, 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
    PA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION B5: ADDITIONAL INFORMATION: THE PHYSICIAN REPORTED THAT THE TARGET NODULE MEASURED 30 X 36 X 31 MILLIMETERS AND WAS LOCATED IN THE RIGHT UPPER LOBE. DURING THE PROCEDURE, THE PATIENT EXPERIENCED CARDIAC ARREST TREATED WITH MULTIPLE ROUNDS OF CARDIOPULMONARY RESUSCITATION (CPR) AND ADMINISTRATION OF MEDICATIONS. THE PHYSICIAN REPORTED THAT THE CAUSE OF DEATH WAS PRESUMED TO BE CARDIAC ARREST SECONDARY TO ACUTE MYOCARDIAL INFARCTION, WITH CONTRIBUTING COMORBIDITIES OF SEVERE CHRONIC OBSTRUCTIVE PULMONARY DISEASE AND HYPERTENSION. THE PHYSICIAN CONFIRMED THAT THERE WAS NO DEVICE ISSUE OR MALFUNCTION RELATED TO THE EVENT.

    Additional Manufacturer Narrative · 0

    AN ION PRODUCT WAS NOT RETURNED TO INTUITIVE SURGICAL, INC. (ISI) FOR EVALUATION. SYSTEM LOGS ARE NOT AVAILABLE FOR REVIEW. A REVIEW OF THE EVENT PERFORMED BY AN INTUITIVE SURGICAL MEDICAL SAFETY OFFICER (MSO) CONCLUDED THAT A PATIENT WHO UNDERWENT AN ION LUNG BIOPSY, DIED. THE PROCEDURE WAS COMPLETED AND BIOPSIES WERE OBTAINED. AFTER THE PROCEDURE WAS COMPLETED AND THE ION SYSTEM WAS UNDOCKED, HYPOTENSION AND BRADYCARDIA WERE NOTED. DESPITE IMMEDIATE RESPONSE BY THE MEDICAL TEAM, THE PATIENT DIED. THERE WAS NO ALLEGATION OF ANY MALFUNCTION OF THE ION SYSTEM, INSTRUMENTS OR ACCESSORIES. ATTEMPTS AT OBTAINING FURTHER INFORMATION HAVE BEEN UNSUCCESSFUL. BASED ON THE AVAILABLE DATA, THE EVENTS WERE LIKELY PROCEDURE RELATED AND NOT DEVICE RELATED. HOWEVER, THERE IS INSUFFICIENT DATA FOR FURTHER ANALYSIS. BRONCHOSCOPY IS A MINIMALLY INVASIVE PROCEDURE WITH A LOW RISK PROFILE. A RETROSPECTIVE STUDY OF (B)(4) BRONCHOSCOPIES REPORTED 4 ASSOCIATED DEATHS (B)(4). ANOTHER PROSPECTIVE MULTICENTER INTERNATIONAL STUDY OF (B)(4) REPORTED 1 ASSOCIATED DEATH (B)(4). A RECENT META-ANALYSIS OF NAVIGATIONAL BRONCHOSCOPY IN (B)(4) PATIENTS REPORTED AN OVERALL ADVERSE EVENT RATE OF (B)(4) WITH 1 DEATH. A CASE SERIES OF ION ROBOTIC ASSISTED BRONCHOSCOPIES PUBLISHED AFTER THE META-ANALYSIS INCLUDING 415 CASES REPORTED NO DEATHS. 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. 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

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER AN ION LUNG BIOPSY PROCEDURE, THE PATIENT EXPERIENCED AN UNSPECIFIED CARDIAC EPISODE, THEIR STATUS DETERIORATED, AND THEY ULTIMATELY EXPIRED. THE BIOPSY PROCEDURE WAS UNEVENTFUL AND COMPLETED AS PLANNED. SHORTLY AFTER THE ION SYSTEM WAS UNDOCKED, THE PATIENT¿S HEART RATE AND BLOOD PRESSURE SUDDENLY DROPPED. RESUSCITATION EFFORTS WERE UNSUCCESSFUL. THERE WAS NO REPORT OF ANY MALFUNCTIONS OR ISSUES INVOLVING THE ION SYSTEM. MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION FROM THE PHYSICIAN WERE MADE; HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2702972 ION SYSTEM CART EOQ INTUITIVE SURGICAL, INC 380748-63 N/A 00886874116234

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Female Death| R ION ENDOLUMINAL SYSTEM.