BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 20677260 · Received November 13, 2024

    Report

    Report Number
    2955842-2024-21703
    Event Type
    Injury
    Date Received
    November 13, 2024
    Date of Event
    October 17, 2024
    Report Date
    October 18, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110720
    PMA / PMN Number
    K131861
    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

    BASED ON THE INFORMATION PROVIDED, THE CAUSE OF THE REPORTED COMPLICATION CANNOT BE DETERMINED. THERE IS NO REPORT OF A MALFUNCTION OF A DA VINCI DEVICE/PRODUCT. A REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE WAS CONDUCTED. INVESTIGATION REVEALED THERE WERE NO RELATED SYSTEM ERRORS TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE THAT WOULD HAVE LIKELY CAUSED OR CONTRIBUTED TO THE REPORTED COMPLAINT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED GASTRIC BYPASS (ROUX-EN-Y) PROCEDURE, THE CASE WAS ABORTED DUE TO THE PATIENT FALLING OFF THE OPERATING ROOM TABLE. AFTER TARGETING WAS COMPLETE AND THE ENDOSCOPE CAMERA WAS DOCKED, THE PATIENT ROLLED TO THE SIDE AND SLID OFF THE TABLE. THE PATIENT WAS REPORTED TO BE IN SUPINE POSITION AT THE TIME OF THE EVENT, IT WAS UNKNOWN IF ANY SAFETY BELTS WERE APPLIED TO THE PATIENT PRIOR TO START OF THE PROCEDURE. THE PROCEDURE WAS ABORTED DUE TO THE FALL, AND THE PATIENT RECEIVED A CT SCAN FOR FURTHER EVALUATION. IT WAS NOTED THAT THE PATIENT INJURY WAS NOT A RESULT OF A DA VINCI SYSTEM ERROR OR COMPLICATIONS. THE OPERATING ROOM TABLE WAS NOT A TRUMPF TABLE. THE PATIENT WAS REPORTEDLY STABLE. IT IS UNKNOWN IF ANY MEDICAL INTERVENTION WAS REQUIRED DUE TO THE FALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2307108 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-56 N/A 00886874110720

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention DA VINCI INSTRUMENTS AND ACCESSORIES