BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ION

    MDR report key: 21997579 · Received May 9, 2025

    Report

    Report Number
    2955842-2025-18283
    Event Type
    Injury
    Date Received
    May 9, 2025
    Date of Event
    March 14, 2025
    Report Date
    April 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 AVAILABLE LOGS DID NOT FIND ANY ERRORS THAT WERE RELEVANT TO THE REPORTED EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ION ENDOLUMINAL LUNG BIOPSY PROCEDURE AND DEVELOPED A PNEUMOTHORAX REQUIRING PLACEMENT OF A CHEST TUBE AND HOSPITALIZATION. THE BIOPSIED LESION WAS 1.5 CM IN SIZE AND LOCATED IN THE LEFT UPPER LOBE, ANTERIOR SEGMENT. BIOPSY TOOLS USED INCLUDED A CYTOLOGY BRUSH (OTHER BRAND) AND BRONCHOALVEOLAR LAVAGE. THE IMAGING MODALITIES USED WERE C-ARM FLUOROSCOPY, IMAGING MODALITIES INCLUDED A CONE BEAM AND RADIAL ENDOBRONCHIAL ULTRASOUND (EBUS). STAGING UTILIZING EBUS WAS PERFORMED. THE DIAGNOSIS OBTAINED FROM PATHOLOGY WAS ADENOCARCINOMA (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
    1131013 ION SYSTEM CART EOQ INTUITIVE SURGICAL, INC 380748-60 N/A 00886874116234

    Patients

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