BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ION

    MDR report key: 25224777 · Received May 19, 2026

    Report

    Report Number
    2955842-2026-25721
    Event Type
    Injury
    Date Received
    May 19, 2026
    Date of Event
    August 7, 2025
    Report Date
    May 19, 2026
    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
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WAS NO REPORT THAT AN ION SYSTEM, INSTRUMENT OR ACCESSORY MALFUNCTIONED DURING THE PROCEDURE. A REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE REVEALED THERE WERE NO RELATED SYSTEM ERRORS TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE THAT WOULD HAVE LIKELY CAUSED OR CONTRIBUTED TO THE REPORTED COMPLAINT.

    Description of Event or Problem · 0

    A PATIENT IN A STUDY UNDERWENT AN ION LUNG BIOPSY PROCEDURE. AFTER THE PROCEDURE THE PATIENT WAS NOTED TO HAVE BLEEDING, CLASSIFIED AS NASHVILLE SCALE GRADE 2, REQUIRING MULTIPLE ALIQUOTS OF COLD SALINE. THE INVESTIGATOR BELIEVES THE CAUSE OF THE BLEEDING TO BE THE FLEXISION NEEDLE AND CRYOPROBE. THE AMOUNT OF BLOOD LOSS WAS NOT RECORDED. HEMOSTASIS WAS ACHIEVED BY THE END OF THE PROCEDURE AND THE EVENT WAS REPORTED AS RESOLVED. THE LESION OF THE RIGHT LOWER LOBE MEASURED 20 X 24 X 18 MM. THE TOOLS USED INCLUDE 23G FLEXISION NEEDLE AND CRYOPROBE - 1.1 MM. THE INSTRUMENT DISTANCE FROM THE NEAREST PLEURA WAS 6 MM. THE PROCEDURE WAS COMPLETED AS PLANNED AND DISCHARGE OCCURRED THE SAME DAY WITH NO FURTHER COMPLICATIONS REPORTED. THE PATIENT¿S RELEVANT COMORBIDITIES REPORTED WERE A HISTORY OF SYSTEMIC HYPERTENSION, CORONARY ARTERY DISEASE, EMPHYSEMA, COPD (GOLD GRADE UNKNOWN), TYPE II DIABETES. THE PATIENT WAS A PREVIOUS SMOKER WITH A 64-PACK-YEAR. THERE WAS NO REPORT OF A DA VINCI DEVICE MALFUNCTION DURING THE PROCEDURE. THE STUDY INVESTIGATOR REPORTED THE EVENT AS NOT A SERIOUS ADVERSE EVENT (SAE), COMMON TERMINOLOGY FOR CRITERIA FOR ADVERSE EVENTS (CTCAE) GRADE 2, NOT RELATED TO THE ION SYSTEM, PROBABLY RELATED TO THE PROCEDURE, AND NOT RELATED TO THE PATIENT¿S EXISTING CONDITION(S).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    402850 ION SYSTEM CART EOQ INTUITIVE SURGICAL, INC 380748-55 N/A 00886874116234

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Female Required Intervention DA VINCI INSTRUMENTS AND ACCESSORIES.