BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ION

    MDR report key: 21767383 · Received April 3, 2025

    Report

    Report Number
    2955842-2025-11759
    Event Type
    Injury
    Date Received
    April 3, 2025
    Date of Event
    March 10, 2025
    Report Date
    March 10, 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
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A SYSTEM LOG REVIEW CANNOT BE PERFORMED BECAUSE THE SYSTEM LOGS ARE NOT AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN ION ENDOLUMINAL LUNG BIOPSY PROCEDURE, HEAVY BLEEDING WAS OBSERVED. INITIALLY, THE PHYSICIAN TRIED TO RETRIEVE THE NODULE WITHOUT USING THE ION SYSTEM, BUT METHODS WERE NOT SUCCESSFUL. THEREFORE, THE CUSTOMER DECIDED TO USE THE ION DEVICE. AT THE END OF THE PROCEDURE AND AFTER USING FORCEPS, THE CUSTOMER WENT TO DO A BRONCHOALVEOLAR LAVAGE (BAL) ON THE AREA. AT THAT TIME, THE CUSTOMER NOTICED HEAVY BLEEDING. THE PHYSICIAN WAS TAKING THE ION OUT AS THE BLEEDING OCCURRED SO IT WAS BELIEVED THAT THE BLEEDING WAS NOT CAUSED BY ANY MALFUNCTION OF THE ION SYSTEM. THE EXACT AMOUNT OF BLOOD LOSS WAS UNKNOWN, BUT THE PHYSICIAN REQUESTED 2 UNITS OF BLOOD FOR TRANSFUSION AND MEDICATION WAS ADMINISTERED TO CONTROL THE BLEEDING. 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
    1957599 ION SYSTEM CART EOQ INTUITIVE SURGICAL, INC 380748-60 UNKNOWN 00886874116234

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention ION ENDOLUMINAL SYSTEM