BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ION

    MDR report key: 20293432 · Received September 24, 2024

    Report

    Report Number
    2955842-2024-19617
    Event Type
    Injury
    Date Received
    September 24, 2024
    Report Date
    August 28, 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
    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. A SYSTEM LOG REVIEW WAS NOT PERFORMED AS THE CONSOLE PHYSICIAN, SYSTEM NAME/SERIAL NUMBER, AND FACILITY NAME WERE NOT PROVIDED.

    Description of Event or Problem · 0

    A SOCIAL MEDIA POST WAS REVIEWED THAT DESCRIBED A SCENARIO OF A LEFT LOWER LOBE NODULE BIOPSY THAT WAS PERFORMED WITH "0.6MM CUTS" AND ¿BY A GOOD PHYSICIAN WITH EXPERIENCE USING THE ION [SYSTEM].¿ THE POST STATED THAT THE BIOPSY RESULTS WERE ¿NON-DIAGNOSTIC¿ AND THE PROCEDURE ¿WAS COMPLICATED BY A LARGE PNEUMOTHORAX REQUIRING A CHEST TUBE AND OVERNIGHT STAY¿ AT THE HOSPITAL. THE POST INDICATED THAT ¿THE INABILITY TO FIX CT TO BODY DIVERGENCE THAT IS INHERENT IN SHAPE SENSING (AND EMN) IS ONE OF THE FLAWS OF THE FIRST-GENERATION ROBOTICS.¿ MULTIPLE EMAIL ATTEMPTS TO CONTACT THE POSTING PHYSICIAN FOR ADDITIONAL INFORMATION WERE NOT SUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1879030 ION SYSTEM CART EOQ INTUITIVE SURGICAL, INC 380748-61 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose Hospitalization| R ION ENDOLUMINAL SYSTEM