BEUDAMED
    FDA Adverse Event Death Summary report: N

    ION ROBOTIC BRONCHOSCOPY

    MDR report key: 20181124 · Received September 9, 2024

    Report

    Report Number
    MW5159363
    Event Type
    Death
    Date Received
    September 9, 2024
    Date of Event
    July 1, 2024
    Report Date
    September 4, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    EOQ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    A 64 Y/O MALE WITH AIR EMBOLISM IN BRAIN POST ROBOTIC NAVIGATION LUNG BIOPSY. ADMITTED TO NEURO ICU AND THEN TRANSFERRED TO HIGHER LEVEL OF CARE, HYPERBARIC TREATMENT. PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2297946 ION ROBOTIC BRONCHOSCOPY BRONCHOSCOPE (FLEXIBLE OR RIGID) EOQ INTUITIVE SURGICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male Death