BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ION

    MDR report key: 21431946 · Received February 21, 2025

    Report

    Report Number
    2955842-2025-01908
    Event Type
    Injury
    Date Received
    February 21, 2025
    Date of Event
    January 9, 2025
    Report Date
    January 27, 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
    NY, 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. SYSTEM LOGS FOR THE EVENT DATE WERE NOT AVAILABLE FOR REVIEW. BLANK MDR FIELDS: THE MISSING PATIENT/DEVICE INFORMATION IN SECTIONS A, B, AND D WAS EITHER UNKNOWN, UNAVAILABLE, NOT PROVIDED, OR NOT APPLICABLE. THE EXPIRATION DATE FOR SECTION D4 IS NOT APPLICABLE. FIELD D6 IS BLANK BECAUSE THE PRODUCT IS NOT IMPLANTABLE. FIELD E4 IS BLANK BECAUSE IT IS UNKNOWN IF THE INITIAL REPORTER SUBMITTED A REPORT TO THE FDA. FIELDS G5 AND G7 ARE NOT APPLICABLE.

    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 BIOPSIED LESION WAS 0.8 CM AND WAS LOCATED IN THE RIGHT LOWER LOBE - LATERAL SEGMENT. IMAGING MODALITIES USED INCLUDED C-ARM FLUOROSCOPY, CONE BEAM, AND RADIAL ENDOBRONCHIAL ULTRASOUND (EBUS); STAGING UTILIZING EBUS WAS PERFORMED. THE DIAGNOSIS OBTAINED FROM PATHOLOGY WAS ATYPICAL CELLS (NON-DIAGNOSTIC). 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
    1787176 ION SYSTEM CART EOQ INTUITIVE SURGICAL, INC 380748-65 N/A 00886874116234

    Patients

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