BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 21789655 · Received April 7, 2025

    Report

    Report Number
    2955842-2025-12740
    Event Type
    Malfunction
    Date Received
    April 7, 2025
    Date of Event
    March 5, 2025
    Report Date
    March 13, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE INFORMATION PROVIDED, THE CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT BE DETERMINED. PER DA VINCI XI SURGICAL SYSTEM IN-SERVICE GUIDE, ENERGY CORDS SHOULD BE CONNECTED TO THE INSTRUMENT HOUSING PRIOR TO INSTRUMENT BEING DOCKED TO THE USM. FURTHERMORE, PER DA VINCI INSTRUCTIONS FOR USE (IFU), USERS SHOULD ALWAYS USE PROPER STRAIN RELIEF ON INSTRUMENTS, ENDOSCOPES, OR ACCESSORIES WITH EXTERNAL ATTACHMENTS, TO AVOID EXERTING EXTERNAL FORCES ON AN ARM THAT COULD CAUSE UNINTENDED MOTION. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WENT TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE CUSTOMER REPORTED ISSUE. THE FSE TESTED THE SYSTEM TO SEE IF INSTRUMENTS WOULD INSERT ON THEIR OWN. THE FSE TRIED MULTIPLE INSTRUMENTS IN MULTIPLE CONFIGURATIONS AND WAS NOT ABLE TO REPRODUCE THE ISSUE UNDER NORMAL CONDITIONS. THE FSE WAS ABLE TO ADVANCE THE INSTRUMENTS IF THE CLUTCH BUTTON WAS PUSHED AND THE BLUE LED WAS BLINKING, AS DESIGNED. THE FSE WAS ALSO ABLE TO ADVANCE INSTRUMENTS WHEN DOING AN INSTRUMENT EXCHANGE AND WITH A BLINKING GREEN LED. THE FSE INDICATED THAT AT NO OTHER TIME COULD THE INSTRUMENTS BE INSERTED WITHOUT EXCESSIVE FORCE TO OVERCOME THE MOTOR FRICTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING DA VINCI-ASSISTED HIATAL HERNIA REPAIR PROCEDURE, UNIVERSAL SURGICAL MANIPULATOR (USM) #4 ADVANCED UNEXPECTEDLY. THE USM #4, WITH A PERMANENT CAUTERY HOOK (PCH) INSTRUMENT INSTALLED, MOVED UNINTENDEDLY WHILE THE BEDSIDE ASSIST ATTACHED THE MONOPOLAR GREEN CORD TO THE INSTRUMENT HOUSING. AFTER PLUGGING IN THE CORD, THE CUSTOMER CLAIMED THE PCH INSTRUMENT ADVANCED ON IT'S OWN ALONG THE INSERTION AXIS WITH NOBODY TOUCHING THE USM. THE INSTRUMENT PUSHED INTO THE DIAPHRAGM CAUSING A 1MM TEAR. NO INTERVENTION WAS REQUIRED TO ADDRESS THE INJURY. THE PROCEDURE WAS COMPLETED ROBOTICALLY WITH NO FURTHER COMPLICATIONS. THE SURGEON ATTRIBUTED THE EVENT TO THE ERBE GENERATOR, PRODUCING A CONNECTION ERROR; THE SURGICAL TEAM WAS TROUBLESHOOTING THE ENERGY CONNECTION DURING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1048122 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-50 N/A

    Patients

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