BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ION

    MDR report key: 18375685 · Received December 21, 2023

    Report

    Report Number
    2955842-2023-21209
    Event Type
    Injury
    Date Received
    December 21, 2023
    Date of Event
    December 1, 2023
    Report Date
    December 4, 2023
    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
    IA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A SYSTEM LOG REVIEW CANNOT BE PERFORMED BECAUSE THE SYSTEM LOGS ARE NOT AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER AN ION ENDOLUMINAL LUNG BIOPSY PROCEDURE, THE PATIENT DEVELOPED A PNEUMOTHORAX REQUIRING A CHEST TUBE AND HOSPITALIZATION. THE PATIENT HAD A MEDICAL HISTORY OF COPD. TWO LESIONS WERE BIOPSIED: LESION #1 WAS 2.2CM AND LOCATED IN THE RIGHT UPPER LOBE AND LESION #2 WAS 1CM AND LOCATED IN THE RIGHT LOWER LOBE. ONE OF THE BIOPSIED LESIONS WAS LOCATED ON THE PLEURA. INSTRUMENTS UTILIZED FOR THE BIOPSY INCLUDED BOTH 21G AND 23G FLEXISION NEEDLES, FORCEPS, CYTOLOGY BRUSH, AND A BRONCHOALVEOLAR LAVAGE WAS PERFORMED. STAGING UTILIZING ENDOBRONCHIAL ULTRASOUND WAS ALSO PERFORMED. PER THE PHYSICIAN, THE NEEDLE MALFUNCTIONED, WHICH RESULTED IN THE NEEDLE HUB THRUSTING FORWARD OUT OF THE NEEDLE SHEATH, AND THE INCONSISTENT EXTENSION OF THE NEEDLE COMPROMISED THE ABILITY TO CONTROL NEEDLE ADVANCEMENT. THE PROCEDURE WAS COMPLETED, AND AFTERWARDS, THE PATIENT EXPERIENCED HYPOXIA AND SHORTNESS OF BREATH. A CHEST TUBE WAS INSERTED, THEN THE PATIENT WAS HOSPITALIZED FOR 48 HOURS PRIOR TO BEING DISCHARGED HOME. THE PHYSICIAN BELIEVED A PNEUMOTHORAX COULD HAVE POSSIBLY OCCURRED WITH ANOTHER BIOPSY MODALITY. THE PRELIMINARY DIAGNOSIS FROM RAPID ON-SITE EVALUATION WAS THE PRESENCE NEOPLASM (MALIGNANT) FOR LESION #1 AND LESION #2 WAS NON-DIAGNOSTIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    304770 ION SYSTEM CART EOQ INTUITIVE SURGICAL, INC 380748-63 UNKNOWN 00886874116234

    Patients

    Seq Age Sex Outcome Treatment
    1 Female ION ENDOLUMINAL SYSTEM