BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ION

    MDR report key: 17116916 · Received June 13, 2023

    Report

    Report Number
    2955842-2023-16253
    Event Type
    Injury
    Date Received
    June 13, 2023
    Date of Event
    May 5, 2023
    Report Date
    May 17, 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
    AZ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE INFORMATION PROVIDED, THE ROOT CAUSE OF THE CUSTOMER REPORTED COMPLICATION CANNOT BE DETERMINED. THERE WAS NO ALLEGATION THAT A MALFUNCTION OF AN ION SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. A SYSTEM LOG REVIEW COULD NOT BE PERFORMED BECAUSE THE SYSTEM LOGS WERE NOT AVAILABLE.

    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 IN THE RIGHT LUNG UPPER LOBE (ANTERIOR SEGMENT). TOOLS UTILIZED WERE THE 21G FLEXISION NEEDLE WITH COMPATIBLE FORCEPS AND CYTOLOGY BRUSH. IMAGING MODALITIES INCLUDED A C-ARM FLUOROSCOPY, CONE BEAM AND RADIAL ENDOBRONCHIAL (EBUS). THE BIOPSY REVEALED A DIAGNOSIS OF ADENOCARCINOMA (MALIGNANT). THERE WAS NO ALLEGATION THAT A MALFUNCTION OF AN ION SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. INTUITIVE SURGICAL, INC. (ISI) MADE MULTIPLE ATTEMPTS TO CONTACT THE PHYSICIAN TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. AS OF THE DATE OF THIS REPORT, NO NEW INFORMATION HAD BEEN OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2215892 ION SYSTEM CART EOQ INTUITIVE SURGICAL, INC 380748-44 UNKNOWN 00886874116234

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown ION ENDOLUMINAL SYSTEM