BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 20592698 · Received November 1, 2024

    Report

    Report Number
    2955842-2024-21484
    Event Type
    Malfunction
    Date Received
    November 1, 2024
    Date of Event
    October 3, 2024
    Report Date
    October 3, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110720
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) ADDRESSED THE REPORTED EVENT WITH PHONE SUPPORT. THE ISSUE WAS RESOLVED BY CUSTOMER POWER CYCLING THE SYSTEM. NO SITE VISIT WAS CONDUCTED. THE SYSTEM WAS WORKING PROPERLY, AND NO ADDITIONAL ACTION WAS REQUIRED AS THE ISSUE WAS RESOLVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED BENIGN HYSTERECTOMY SURGICAL PROCEDURE, THE CUSTOMER CALLED IN AFTER THE PROCEDURE TO REPORT THE SURGEON COMPLAINED ABOUT UNIVERSAL SURGICAL MANIPULATOR (USM) 2 AND USM3 BEING JITTERY AND NOT MOVING CORRECTLY. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) FOUND NO RELATED ERRORS AND SHARED THAT ISSUE MIGHT HAVE BEEN INSTRUMENT OR STERILE ADAPTER RELATED. THE TSE WAS NOT ABLE TO HELP TROUBLESHOOTING SINCE CASE WAS OVER BUT WALKED THE CUSTOMER THROUGH A POWER CYCLE OF THE SYSTEM FOR THEIR FOLLOWING PROCEDURE. THE SYSTEM POWERED BACK ON WITHOUT ISSUE AND NO ERRORS WERE FOUND. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2160805 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-48 N/A 00886874110720

    Patients

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