BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ION

    MDR report key: 21360692 · Received February 11, 2025

    Report

    Report Number
    2955842-2025-00890
    Event Type
    Injury
    Date Received
    February 11, 2025
    Date of Event
    November 22, 2024
    Report Date
    January 14, 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
    WI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE SITE'S SYSTEM LOGS FOUND NO OBSERVED EVENTS THAT WOULD SUGGEST A PRODUCT ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ION ENDOLUMINAL LUNG BIOPSY PROCEDURE AND DEVELOPED A PNEUMOTHORAX REQUIRING PLACEMENT OF A CHEST TUBE AND HOSPITALIZATION. THE BIOPSIED LESION WAS 1.0 CM IN SIZE AND LOCATED IN THE RIGHT MIDDLE LOBE, LATERAL SEGMENT. TOOLS USED DURING THE CASE INCLUDED A 23G FLEXISION NEEDLE, CYTOLOGY BRUSH (OTHER BRAND), AND BRONCHOALVEOLAR LAVAGE. IMAGING MODALITIES USED WERE C-ARM FLUOROSCOPY, CONE BEAM, AND RADIAL ENDOBRONCHIAL ULTRASOUND (EBUS); STAGING UTILIZING EBUS WAS PERFORMED. THE DIAGNOSIS OBTAINED FROM PATHOLOGY WAS SQUAMOUS CELL CARCINOMA (MALIGNANT). THERE IS 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
    984881 ION SYSTEM CART EOQ INTUITIVE SURGICAL, INC 380748-60 N/A 00886874116234

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose Hospitalization| R ION ENDOLUMINAL SYSTEM.