BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 24516053 · Received March 5, 2026

    Report

    Report Number
    2955842-2026-15089
    Event Type
    Malfunction
    Date Received
    March 5, 2026
    Date of Event
    February 12, 2026
    Report Date
    April 21, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110898
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL INC. (ISI) RECEIVED THE INTEGRATED ELECTROSURGICAL UNIT (IESU) FOR FAILURE ANALYSIS INVESTIGATION. THE UNIT WAS ANALYZED AND LARGE NUMBER OF M-11 C-38, C-30, M-18 ERRORS LOGGED. M-19 ERROR LOGGED, C-37, M-02 LOGGED. FA INSPECTION WAS ABLE TO CONFIRM AND REPLICATE THE REPORTED EVENT; UNIT TESTED ON SYSTEM, PRESENTS C-38 ERROR ON MONO 2 COAG. ERRORS SELF-CLEARING, PHANTOM TOUCH INPUT DISCOVERED VIA TP DISPLAY SERVICE ROUTINE. C-00, M-02, M-19, M-11 ERRORS IN ERBE LOGS. THE PROBABLE ROOT CAUSE OF THIS ISSUE IS ATTRIBUTED TO FAULTY ELECTRICAL COMPONENT INSIDE THE ERBE GENERATOR.

    Additional Manufacturer Narrative · 0

    AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. THE FSE WENT ON-SITE AND PERFORMED SYSTEM TEST DRIVE AND FOUND ERRORS C-00, M-18, AND M-11 OCCURRING ON ERBE. THE FSE REPLACED THE INTEGRATED ELECTROSURGICAL UNIT (IESU). THE SYSTEM WAS VERIFIED AND READY FOR USE. INTUITIVE SURGICAL, INC. (ISI) HAS NOT RECEIVED THE DA VINCI PRODUCT WITH AN ALLEGED ISSUE TO PERFORM FAILURE ANALYSIS. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE PRODUCT IS RETURNED AND EVALUATED AND/OR IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED BENIGN HYSTERECTOMY SURGICAL PROCEDURE, USER INFORMED THE TECHNICAL SUPPORT ENGINEER (TSE) THAT THE ERBE UNIT CONTINUED TO FAULT WITH ERRORS C-30, M-11, M-18, AND C-38 EVEN AFTER USING BRAND NEW ENERGY CABLES AND REBOOTING THE UNIT. THE USER REPLACED THE ERBE GENERATOR WITH A THIRD-PARTY ENERGY DEVICE TO CONTINUE WITH THE PROCEDURE AS PLANNED. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376103 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-38 N/A 00886874110898

    Patients

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