BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 22573441 · Received July 23, 2025

    Report

    Report Number
    2955842-2025-31196
    Event Type
    Malfunction
    Date Received
    July 23, 2025
    Date of Event
    June 27, 2025
    Report Date
    June 27, 2025
    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
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INTUITIVE SURGICAL INC., (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. FSE REPLACED THE INTEGRATED ELECTROSURGICAL UNIT (IESU) ERBE TO RESOLVE THE REPORTED ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI HAS RECEIVED THE UNIT; HOWEVER, FAILURE ANALYSIS INVESTIGATION ARE STILL ONGOING. ADDITIONAL INFORMATION IS BEING GATHERED TO DETERMINE THE CONTRIBUTION OF THE DEVICE TO THE CUSTOMER REPORTED ISSUE.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE ERBE UNIT WAS ANALYZED, AND FAILURE ANALYSIS INVESTIGATIONS REPLICATED AND CONFIRMED THE CUSTOMER-REPORTED COMPLAINT. THE REPORTED ISSUE WAS CONFIRMED IN THE FIELD AS ERROR 25913: M-02 MODULE TIMEOUT. VISUAL INSPECTION REVEALED STAIN ON THE FRONT BEZEL. DURING STARTUP, THE ERBE UNIT DISPLAYED ERRORS M-02-3,4-71 AND FAILED THE INSTRUMENT DETECTION TEST ON ALL SOCKETS. THE COMPLAINT WAS CONFIRMED BASED ON THE FIELD EVALUATION AND FAILURE ANALYSIS. THE PROBABLE ROOT CAUSE OF ERROR M-02 IS ATTRIBUTED TO A FAULTY COMPONENT OF THE ERBE GENERATOR. M-02 ERRORS INDICATE A MODULE TIMEOUT ISSUE AND, THEREFORE, THE ACTIVATION WAS INTERRUPTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI ASSISTED SURGICAL PROCEDURE, NONE OF THE MONOPOLAR OR BIPOLAR CORDS WERE WORKING. AN INTEGRATED ELECTROSURGICAL UNIT (IESU) ERBE WAS FAULTING WITH ERROR M-02. AN INTUITIVE SURGICAL INC., (ISI) TECHNICAL SUPPORT ENGINEER (TSE) WALKED CUSTOMER THROUGH POWER CYCLE OF ERBE. CUSTOMER WAS UNABLE TO CONFIRM IF ENERGY WAS WORKING AS THEY WERE NOT USING ENERGY INSTRUMENTS AT THE TIME OF CALL. HOWEVER, THE GENERATOR SCREEN LOOKED LIKE IT WILL WORK. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY. AN ISI FIELD SERVICE ENGINEER (FSE) TO FOLLOW-UP.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2724749 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-19 N/A 00886874110898

    Patients

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