BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ION

    MDR report key: 22034681 · Received May 16, 2025

    Report

    Report Number
    2955842-2025-20835
    Event Type
    Injury
    Date Received
    May 16, 2025
    Report Date
    April 16, 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
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A SYSTEM LOG REVIEW COULD NOT BE PERFORMED BECAUSE AN EVENT DATE WAS NOT PROVIDED. 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 UNDERWENT AN ION LUNG BIOPSY AND POSSIBLY EXPERIENCED AN AIR EMBOLISM. NO FURTHER DATA IS AVAILABLE. THERE WAS NO MALFUNCTION OF THE ION SYSTEM, INSTRUMENTS OR ACCESSORIES REPORTED. THERE IS INSUFFICIENT INFORMATION TO DETERMINE WHETHER ANY ADVERSE EVENT OCCURRED NOR WHETHER THE POSSIBLE ADVERSE EVENT MIGHT HAVE BEEN PROCEDURE RELATED. THERE IS NO EVIDENCE THE POSSIBLE ADVERSE EVENT MIGHT HAVE BEEN DEVICE RELATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ION ENDOLUMINAL LUNG BIOPSY PROCEDURE AND POSSIBLY EXPERIENCED AN AIR EMBOLISM. NO OTHER INFORMATION WAS PROVIDED. THERE WAS NO ALLEGATION THAT A MALFUNCTION OF AN ION SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1089900 ION SYSTEM CART EOQ INTUITIVE SURGICAL, INC 380748-45 N/A 00886874116234

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening ION ENDOLUMINAL SYSTEM.