BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ION

    MDR report key: 23121639 · Received September 23, 2025

    Report

    Report Number
    2955842-2025-38873
    Event Type
    Injury
    Date Received
    September 23, 2025
    Date of Event
    August 8, 2025
    Report Date
    August 29, 2025
    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
    NM, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WAS NO ALLEGATION THAT A MALFUNCTION OF AN ION SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. A REVIEW OF THE SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE SHOWED THERE WERE NO RELATED SYSTEM ERRORS TO HAVE OCCURRED DURING THE PROCEDURE THAT WOULD HAVE LIKELY CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. A REVIEW OF THE EVENT WAS CONDUCTED BY AN INTUITIVE SURGICAL, INC. (ISI) MEDICAL OFFICER AND THE FOLLOWING ADDITIONAL INFORMATION WAS PROVIDED: A PATIENT OF UNKNOWN AGE AND UNKNOWN MEDICAL HISTORY UNDERWENT AN ION LUNG BIOPSY OF A 1.7CM NODULE IN THE LEFT UPPER LOBE. THE BIOPSY OF THE LUNG NODULE WAS COMPLETED AND RESULTS WERE CONSISTENT WITH A BENIGN ADENOMA. MANUAL LINEAR EBUS BRONCHOSCOPY WAS PERFORMED FOR STAGING. SECTION A PATIENT DEMOGRAPHIC INFORMATION: YEAR OF BIRTH 1961.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ION ENDOLUMINAL LUNG BIOPSY PROCEDURE AND EXPERIENCED A CARDIAC ARREST. THE BIOPSIED NODULE WAS 1.7 CM IN SIZE AND LOCATED IN THE LEFT UPPER LOBE. STAGING UTILIZING ENDOBRONCHIAL ULTRASOUND (EBUS) WAS PERFORMED. THE DIAGNOSIS OBTAINED FROM PATHOLOGY WAS ADENOMA/BRONCHIAL (BENIGN). THERE WAS NO ALLEGATION THAT A MALFUNCTION OF AN ION SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    733498 ION SYSTEM CART EOQ INTUITIVE SURGICAL, INC 380748-65 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| L ION ENDOLUMINAL SYSTEM