BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ION

    MDR report key: 21848809 · Received April 16, 2025

    Report

    Report Number
    2955842-2025-15250
    Event Type
    Injury
    Date Received
    April 16, 2025
    Date of Event
    February 20, 2025
    Report Date
    March 20, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    EOQ
    PMA / PMN Number
    K182188
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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 SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE SHOWED THERE WERE NO RELATED SYSTEM ERRORS TO HAVE OCCURRED DURING THE PROCEDURE THAT WOULD HAVE LIKELY CAUSED OR CONTRIBUTED TO THE REPORTED EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ION ENDOLUMINAL LUNG BIOPSY PROCEDURE AND DEVELOPED A PNEUMOTHORAX REQUIRING A CHEST TUBE AND HOSPITALIZATION. THE LESION WAS 1 CM IN SIZE AND LOCATED IN THE RIGHT MIDDLE LOBE. A 21G FLEXISION NEEDLE AND FORCEPS WERE USED FOR THE BIOPSY PROCEDURE. THE DIAGNOSIS OBTAINED FROM PATHOLOGY WAS METASTATIC TUMOR (MALIGNANT). THERE WAS NO ALLEGATION THAT A MALFUNCTION OF AN ION SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. 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
    106699 ION SYSTEM CART EOQ INTUITIVE SURGICAL, INC 380748-65 N/A

    Patients

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