BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 23068989 · Received September 16, 2025

    Report

    Report Number
    2955842-2025-37829
    Event Type
    Malfunction
    Date Received
    September 16, 2025
    Date of Event
    August 26, 2025
    Report Date
    August 26, 2025
    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
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. THE REPORTED EVENT WAS ADDRESSED WITH PHONE SUPPORT. THE FIELD SERVICE ENGINEER (FSE) CONTACTED THE INTUITIVE SURGICAL, INC. (ISI) REPRESENTATIVE ON SITE AND CONFIRMED THAT THEY RESEATED THE STERILE ADAPTER AND REPLACED INSTRUMENT AS A PRECAUTION. CUSTOMER NOTED THAT THE SURGEON REPORTED NO PERSISTENT ISSUES AFTER RESEATING THE STERILE ADAPTER AND REPLACING THE INSTRUMENT AND NO REOCCURRENCE ON THE FOLLOWING CASE. NO SITE VISIT WAS CONDUCTED. THE SYSTEM WAS WORKING PROPERLY, AND NO ADDITIONAL ACTION WAS REQUIRED AS THE ISSUE WAS RESOLVED. WHILE A DEFINITIVE ROOT-CAUSE OF THE UNINTENDED MOVEMENT CANNOT BE ESTABLISHED SINCE THE PHONE SUPPORT DETAILS DID NOT REVEAL ANY ISSUES RELATED TO THE CUSTOMER REPORTED EVENT, A POTENTIAL/COMMON ROOT CAUSE FOR THIS FAILURE CAN BE ATTRIBUTED TO USER-INDUCED FACTORS SUCH AS THE SURGEON RELEASING A MASTER TOOL MANIPULATOR (MTM) DURING FOLLOWING MODE WHILE THEIR HEAD IS IN THE HIGH RESOLUTION STEREO VIEWER (HRSV) OR A USER APPLYING EXTERNAL FORCE TO AN ARM ON THE PATIENT SIDE CART (PSC) (E.G., ENERGY CABLE CONNECTION) THAT IS BEING COMMANDED BY THE SURGEON.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MALIGNANT HYSTERECTOMY SURGICAL PROCEDURE, THE INSTRUMENT ON UNIVERSAL SURGICAL MANIPULATOR (USM) 4, WHICH WAS STATICALLY GRASPING THE PATIENT¿S TISSUE, MOVED SLIGHTLY WHILE THE SURGEON WAS USING THE GIVE ALL/TAKE ALL FEATURE. THE CUSTOMER RECEIVED PHONE ASSISTANCE FROM INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE). THE CUSTOMER EXPLAINED THAT USM1 AND USM3 WERE CONTROLLED BY SURGEON SIDE CONSOLE (SSC) 2, AND USM4 WAS CONTROLLED BY SSC1. THE CUSTOMER CONFIRMED THAT WHEN THE ISSUE FIRST OCCURRED, THE SURGEON RELEASED HANDS FROM THE HAND CONTROL WITHOUT REMOVING HEAD FROM THE VIEWER. IT WAS UNCERTAIN IF THIS SEQUENCE WAS REPEATED THE SECOND TIME. SYSTEM LOGS BEYOND THE "START OF FOLLOWING" WERE UNAVAILABLE DURING THE CALL. THE CUSTOMER RESEATED STERILE ADAPTER (SA) AND REPLACED THE INSTRUMENT TO CONTINUE WITH THE PROCEDURE. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2650831 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-50 N/A 00886874110720

    Patients

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