BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 21183793 · Received January 17, 2025

    Report

    Report Number
    2955842-2025-00495
    Event Type
    Malfunction
    Date Received
    January 17, 2025
    Date of Event
    December 30, 2024
    Report Date
    December 30, 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
    NH, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. FSE WAS UNABLE TO REPRODUCE THE REPORTED PROBLEM. FSE WAS ABLE TO SWAP INSTRUMENTS BETWEEN ALL USM'S WITH NO ISSUES. SYSTEM TESTED AND VERIFIED AS READY FOR USE. THE COMPLAINT WAS NOT CONFIRMED BASED ON FIELD EVALUATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL CHOLECYSTECTOMY PROCEDURE, THE INTUITIVE REPRESENTATIVE INFORMED THE TECHNICAL SUPPORT ENGINEER (TSE) WHEN SWAPPING THE INSTRUMENT THEY DIDN¿T GET GUIDED TOOL CHANGE. THE REP ADDITIONALLY DETAILED THAT CUSTOMER WOULD MANUALLY INSERT INSTRUMENT AND WAS GETTING RESISTANCE WHILE ADVANCING AND THEN AFTER ADVANCING THE INSTRUMENT MOVES FURTHER FORWARD ON UNIVERSAL SURGICAL MANIPULATOR (USM)3. THERE WERE NO RELATED ERRORS IN LOGS. THE TSE ASKED TO HAVE THE CUSTOMER CONFIRM NO DRAPE INTERFERENCE AND TO ENSURE THEY WERE NOT OPERATING JUST PAST THE CANNULA TIP. THE TSE ASKED IF THE CUSTOMER USES THE CANNULA GAUGE PINS AND THE CUSTOMER STATED THEY LIKELY DO NOT. THE TSE ADVISED POSSIBLY DENTED CANNULA CREATING RESISTANCE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1016786 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-46 N/A 00886874110720

    Patients

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