BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 22918980 · Received August 28, 2025

    Report

    Report Number
    2955842-2025-36034
    Event Type
    Malfunction
    Date Received
    August 28, 2025
    Date of Event
    August 11, 2025
    Report Date
    August 11, 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 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 INTEGRATED ELECTROSURGICAL UNIT (IESU) OR ERBE TO DUE TO ERROR U-02. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. THE COMPLAINT WAS CONFIRMED BASED ON FIELD EVALUATION. A RETURN MATERIAL AUTHORIZATION (RMA) HAS BEEN ISSUED FOR THE RETURN OF THE ERBE. .

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE INTEGRATED ELECTROSURGICAL UNIT (IESU) OR ERBE GENERATOR WAS ANALYZED AND FOUND THE REPEATED U-02 ERROR ON THE ERBE WAS CONFIRMED VIA SYSTEM LOGS. NO RELATED ISSUES WERE FOUND ON VISUAL INSPECTION, BUT THE ERROR REAPPEARED AFTER POWERING ON. THE UNIT WILL BE SENT TO THE ORIGINAL EQUIPMENT MANUFACTURER FOR FURTHER INVESTIGATION. THE PROBABLE CAUSE OF ERROR U-02 IS ATTRIBUTED TO A FAULTY ERBE GENERATOR. THIS ERROR INDICATES INTEGRATED ELECTROSURGICAL UNIT CHECK MASTER FAILURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE INTEGRATED ELECTROSURGICAL UNIT (IESU) OR ERBE HAD REPEATED U-02 ERRORS AND WAS POWER CYCLED MULTIPLE TIMES. IT WAS EXPLAINED THAT A REPEATED U-02 ERROR WILL REQUIRE THAT THE ERBE GENERATOR IS REPLACED. SITE USED FORCE TRIAD GENERATOR TO CONTINUE WITH THE PROCEDURE AS PLANNED. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1828246 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