BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ION

    MDR report key: 19154152 · Received April 22, 2024

    Report

    Report Number
    2955842-2024-13296
    Event Type
    Injury
    Date Received
    April 22, 2024
    Date of Event
    January 19, 2024
    Report Date
    March 26, 2024
    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
    GA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 PLACEMENT OF A CHEST TUBE AND HOSPITALIZATION. THE BIOPSIED GROUND GLASS LESION WAS 1.9CM IN SIZE AND LOCATED IN THE RIGHT MIDDLE LOBE. RADIAL EBUS WAS UTILIZED TO LOCALIZE THE LESION. INSTRUMENTS USED FOR BIOPSY UNDER C-ARM FLUOROSCOPY (CONE BEAM CT) INCLUDED A 21G FLEXISION NEEDLE (4 PASSES), FORCEPS (6 PASSES), A CYTOLOGY BRUSH (1 PASS), AND A BRONCHOALVEOLAR LAVAGE WAS ALSO PERFORMED. THE PRELIMINARY DIAGNOSIS WAS ATYPICAL CELLS (NON-DIAGNOSTIC). 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
    1686281 ION SYSTEM CART EOQ INTUITIVE SURGICAL, INC 380748-44 UNKNOWN 00886874116234

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown ION ENDOLUMINAL SYSTEM