BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ION

    MDR report key: 20945924 · Received December 16, 2024

    Report

    Report Number
    2955842-2024-23025
    Event Type
    Injury
    Date Received
    December 16, 2024
    Date of Event
    April 22, 2024
    Report Date
    November 22, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    EOQ
    PMA / PMN Number
    K182188
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 1 CM IN SIZE AND LOCATED IN THE LEFT UPPER LOBE. THE DIAGNOSIS OBTAINED FROM PATHOLOGY WAS 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 REGARDING THE EVENT. HOWEVER, THERE WAS NO RESPONSE RECEIVED FROM THE PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2355447 ION SYSTEM CART EOQ INTUITIVE SURGICAL, INC 380748-63 N/A

    Patients

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