BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 24710003 · Received March 30, 2026

    Report

    Report Number
    2955842-2026-19118
    Event Type
    Malfunction
    Date Received
    March 30, 2026
    Date of Event
    November 5, 2025
    Report Date
    March 26, 2026
    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
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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. THE FSE REPLACED THE UNIVERSAL SURGICAL MANIPULATOR (USM) 3 TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI DID RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE USM 3 WAS ANALYZED AND FOUND IN ARTEMIS, THE ¿23118¿ ERROR WAS FOUND INDICATING ¿MOTOR ENCODER INCREMENTAL TRACK HAS SLIPPED¿ ON THE USM AXIS, CONFIRMING THE FAULT OCCURRED IN THE FIELD. UPON VISUAL INSPECTION, NO ISSUE RELATED TO THE REPORTED ISSUE WAS NOTED. THE USM WAS INSTALLED ON AN IN-HOUSE SYSTEM, WHERE THE COMPONENT FUNCTIONED AS EXPECTED. THE USM WAS THEN INSTALLED ON PATIENT SIDE CART (PSC) FIXTURE TEST PLATFORM (PFTP), WHERE CHIPENCODER VIRTUAL ABSOLUTE (CVA) WAS FOUND TO BE FAILING ON THE USM AXIS. ONCE TESTING WAS COMPLETED, THE CHIPENCODER VIRTUAL ABSOLUTE (CVA) FLAT FLEX CABLE (FFC) WAS TESTED AND WAS VERIFIED TO BE THE SOURCE OF THE FAULT. THE COMPLAINT WAS CONFIRMED BASED ON THE RESULTS OF THE INVESTIGATION, WHICH INDICATES THAT THE DEVICE MAY HAVE CONTRIBUTED TO THE CUSTOMER REPORTED ISSUE. A ROOT CAUSE OF THE REPORTED FAILURE WAS ATTRIBUTED TO A DEFECTIVE CHIPENCODER VIRTUAL ABSOLUTE (CVA) FLAT FLEX CABLE (FFC) OF THE USM.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SYSTEM HAD A REPEATED RECOVERABLE FAULT 23118 ON THE UNIVERSAL SURGICAL MANIPULATOR (USM) 3. THE TECHNICAL SERVICE ENGINEER CONFIRMED THE REPORTED ERROR IN THE SYSTEM LOGS. THE CUSTOMER POWER CYCLED THE SYSTEM, BUT THE ISSUE REMAINED. THE TSE EXPLAINED THAT THE ERROR WOULD RECUR WITH A FOUR ARMS PROCEDURE. THE SURGEON ELECTED TO CONVERT TO LAPAROSCOPIC SURGERY. THERE WAS NO REPORTED INJURY. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: IT WAS CONFIRMED THAT THE ISSUE OCCURRED PRIOR TO ANESTHESIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331097 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-53 N/A 00886874110720

    Patients

    Seq Age Sex Outcome Treatment
    1