BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ION

    MDR report key: 23478391 · Received November 5, 2025

    Report

    Report Number
    2955842-2025-42787
    Event Type
    Injury
    Date Received
    November 5, 2025
    Date of Event
    October 10, 2025
    Report Date
    November 5, 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
    KY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE EVENT WAS CONDUCTED BY AN INTUITIVE SURGICAL, INC. (ISI) MEDICAL SAFETY OFFICER AND THE FOLLOWING ADDITIONAL INFORMATION WAS PROVIDED: "A PATIENT OF UNKNOWN AGE UNDERWENT AN ION LUNG BIOPSY AND DIED. THE PATIENT REPORTEDLY HAD SIGNIFICANT MEDICAL CO-MORBIDITIES. THERE WAS NO ALLEGATION OF MALFUNCTION OF THE ION SYSTEM, INSTRUMENTS OR ACCESSORIES. MULTIPLE ATTEMPTS AT OBTAINING FURTHER DATA HAVE BEEN UNSUCCESSFUL. THERE IS INSUFFICIENT INFORMATION TO DETERMINE RELATIONSHIP TO THE PROCEDURE OR TO THE DEVICE."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER AN ION TRANSBRONCHIAL BIOPSY PROCEDURE, THE PATIENT EXPERIENCED AN UNSPECIFIED CARDIAC EVENT THAT REQUIRED CPR. DETAILS REGARDING THE COMPLICATION WERE NOT PROVIDED ALTHOUGH IT WAS SUSPECTED TO BE A CARDIAC EVENT. THE PATIENT WAS STABILIZED. AN X-RAY WAS PERFORMED AND NO PNEUMOTHORAX WAS IDENTIFIED. NO ALLEGATIONS RELATED TO THE ION SYSTEM WERE REPORTED. 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
    2677018 ION SYSTEM CART EOQ INTUITIVE SURGICAL, INC 380748-65 UNKNOWN 00886874116234

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R| L ION ENDOLUMINAL SYSTEM