BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ION

    MDR report key: 19286433 · Received May 10, 2024

    Report

    Report Number
    2955842-2024-14373
    Event Type
    Injury
    Date Received
    May 10, 2024
    Date of Event
    January 24, 2024
    Report Date
    April 17, 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
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WAS NO ALLEGATION THAT A MALFUNCTION OF AN ION SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. A REVIEW OF THE SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE WAS PERFORMED BY AN INTUITIVE SURGICAL, INC. (ISI) FAILURE ANALYSIS ENGINEER. PER THE REVIEW, 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. THERE WERE 2 LESIONS BIOPSIED: 6.6 CM IN SIZE LOCATED IN THE LEFT UPPER LOWER LOBE (SUPERIOR LINGULAR SEGMENT) AND 6.6 CM IN SIZE LOCATED IN THE RIGHT UPPER LOBE (ANTERIOR SEGMENT). INSTRUMENTS UTILIZED DURING BIOPSY INCLUDED A 19G FLEXISION NEEDLE, FORCEPS, A CYTOLOGY BRUSH, AND A BRONCHOALVEOLAR LAVAGE WAS ALSO PERFORMED. ENDOBRONCHIAL ULTRASOUND (EBUS) WAS PERFORMED OUTSIDE OF THE ION PROCEDURE. THE DIAGNOSIS OBTAINED FROM PATHOLOGY FOR LESION #1 WAS GRANULOMA (BENIGN); THE DIAGNOSIS FOR THE SECOND LESION WAS NOT PROVIDED. 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
    2121932 ION SYSTEM CART EOQ INTUITIVE SURGICAL, INC 380748-61 N/A 00886874116234

    Patients

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