BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ION

    MDR report key: 19285868 · Received May 10, 2024

    Report

    Report Number
    2955842-2024-14116
    Event Type
    Injury
    Date Received
    May 10, 2024
    Date of Event
    January 25, 2024
    Report Date
    April 15, 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
    KY, 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 WAS PERFORMED BY AN INTUITIVE SURGICAL, INC. (ISI) FAILURE ANALYSIS ENGINEER (FAE). 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. THE LESION SIZE WAS 1.8 CM IN SIZE AND LOCATED IN THE RIGHT LOWER LOBE (RLL). PER THE PHYSICIAN, THE BIOPSIES CAUSED THE PNEUMOTHORAX. THE DIAGNOSIS OBTAINED FROM PATHOLOGY WAS ADENOCARCINOMA (MALIGNANT). THERE IS NO ALLEGATION THAT A MALFUNCTION OF AN ION SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    982600 ION SYSTEM CART EOQ INTUITIVE SURGICAL, INC 380748-61 UNKNOWN 00886874116234

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R ION ENDOLUMINAL SYSTEM