BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 21546284 · Received March 7, 2025

    Report

    Report Number
    2955842-2025-05505
    Event Type
    Injury
    Date Received
    March 7, 2025
    Date of Event
    February 6, 2025
    Report Date
    February 6, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    NO INTUITIVE SURGICAL, INC. (ISI) PRODUCT HAS BEEN IMPLICATED OR RETURNED FOR FAILURE ANALYSIS (FA). THOUGH NOT IMPLICATED, AN ADVANCED STAPLER LOG REVIEW SHOWS A SUREFORM 60 STAPLER INSTRUMENT PART NUMBER 480460-09 LOT NUMBER K11240924-0009, WAS INSTALLED ON THE SYSTEM ONCE AND FIRED 1 BLUE RELOAD. ON THE ONLY INSTALL, THE FIRST CLAMP WAS SUCCESSFUL, AND THE FIRING WAS COMPLETED WITH NO PAUSES FOR COMPRESSION. THE INSTRUMENT WAS THEN REMOVED AND NOT USED IN THE PROCEDURE AGAIN. THERE WERE NO STAPLER RELATED ERRORS IN THE SYSTEM LOGS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LOWER ANTERIOR RESECTION, A LEAK WAS DETECTED AFTER AN ANASTOMOSIS WITH A THIRD-PARTY CIRCULAR STAPLER AND ACTION WAS TAKEN IMMEDIATELY TO CORRECT THE ANASTOMOSIS. THE REPORTER DID NOT INDICATE HOW THE PROCEDURE WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434668 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC N/A N/A

    Patients

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