BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ION

    MDR report key: 22193716 · Received June 12, 2025

    Report

    Report Number
    2955842-2025-25208
    Event Type
    Injury
    Date Received
    June 12, 2025
    Date of Event
    March 27, 2025
    Report Date
    May 19, 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
    CT, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WAS NO ALLEGATION THAT A MALFUNCTION OF AN ION SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. 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 PROCEDURE THAT WAS RELEVANT TO THE REPORTED EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ION ENDOLUMINAL LUNG BIOPSY PROCEDURE, AND HAD A BLEEDING COMPLICATION REQUIRING MEDICAL INTERVENTION. THE TARGET NODULE WAS 1 CM IN SIZE AND LOCATED IN THE RIGHT UPPER LOBE APICAL SEGMENT. INSTRUMENTS USED FOR BIOPSY INCLUDED A 21G FLEXISION BIOPSY NEEDLE, COMPATIBLE FORCEPS, AND A BRONCHOALVEOLAR LAVAGE PERFORMED. C-ARM FLUOROSCOPY WAS USED FOR INTRA-PROCEDURAL IMAGING AND ULTRASOUND BRONCHOSCOPY (EBUS) WAS USED TO PERFORM STAGING OUTSIDE OF THE ION PROCEDURE. THE PHYSICIAN REPORTED THAT THE PATIENT WAS KNOWN TO BE AT HIGH RISK FOR BLEEDING AND HAD A PRIOR HISTORY OF MUCH WORSE BLEEDING FROM ANOTHER HOSPITAL AND USING A DIFFERENT PLATFORM FOR BIOPSY. INTUITIVE SURGICAL, INC. (ISI) MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2200270 ION SYSTEM CART EOQ INTUITIVE SURGICAL, INC 380748-60 N/A 00886874116234

    Patients

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