BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ION

    MDR report key: 20668466 · Received November 12, 2024

    Report

    Report Number
    2955842-2024-21778
    Event Type
    Injury
    Date Received
    November 12, 2024
    Date of Event
    October 18, 2024
    Report Date
    October 18, 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
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF THE PNEUMOTHORAX CANNOT BE DETERMINED. SYSTEM LOGS WERE NOT AVAILABLE FOR REVIEW AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER AN ION ENDOLUMINAL LUNG BIOPSY PROCEDURE, THE PATIENT HAD DEVELOPED A PNEUMOTHORAX WHICH REQUIRED CHEST TUBE PLACEMENT AND HOSPITALIZATION. THE PATIENT WAS KNOWN TO HAVE HAD A RECENT INTERVENTIONAL RADIOLOGY (IR) COMPUTED TOMOGRAPHY (CT)-GUIDED BIOPSY ON THE SAME NODULE A MONTH PRIOR WITH A COMPLICATION OF PNEUMOTHORAX. THE TARGET NODULE WAS LOCATED IN THE LEFT UPPER LOBE VERY CLOSE TO THE PLEURAL BORDER. FURTHER DETAILS WERE NOT AVAILABLE. THERE WAS NO DEVICE MALFUNCTION ASSOCIATED WITH THE EVENT. INTUITIVE SURGICAL, INC. (ISI) MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1643866 ION SYSTEM CART EOQ INTUITIVE SURGICAL, INC 380748-65 N/A 00886874116234

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose Required Intervention| H DA VINCI INSTRUMENTS AND ACCESSORIES.