BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ION

    MDR report key: 18331059 · Received December 14, 2023

    Report

    Report Number
    2955842-2023-21199
    Event Type
    Injury
    Date Received
    December 14, 2023
    Date of Event
    March 16, 2023
    Report Date
    November 22, 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
    MA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE IS NO ALLEGATION THAT A MALFUNCTION OF AN ION SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. 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 A CHEST TUBE AND HOSPITALIZATION. THE BIOPSIED LESION WAS 2.9CM IN SIZE AND LOCATED IN THE RIGHT LOWER LOBE (SUPERIOR SEGMENT). RADIAL ENDOBRONCHIAL ULTRASOUND (EBUS) AND CONE BEAM CT WERE UTILIZED TO LOCALIZE THE LESION. INSTRUMENTS UTILIZED FOR BIOPSY UNDER C-ARM FLUOROSCOPY INCLUDED A 21G FLEXISION NEEDLE AND A CYTOLOGY BRUSH. STAGING UTILIZING LINEAR EBUS WAS ALSO PERFORMED. THE DIAGNOSIS OBTAINED FROM PATHOLOGY WAS ADENOCARCINOMA (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 HAD BEEN OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1113960 ION SYSTEM CART EOQ INTUITIVE SURGICAL, INC 380748-45 UNKNOWN 00886874116234

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male ION ENDOLUMINAL SYSTEM