BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 22173457 · Received June 10, 2025

    Report

    Report Number
    2955842-2025-24384
    Event Type
    Malfunction
    Date Received
    June 10, 2025
    Date of Event
    May 28, 2025
    Report Date
    June 17, 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
    CA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    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 REPLACED THE INTEGRATED ELECTROSURGICAL UNIT (IESU). THE SYSTEM WAS VERIFIED AND READY FOR USE. INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE UNIT; HOWEVER, FAILURE ANALYSIS IS 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) RECEIVED THE INTEGRATED ELECTROSURGICAL UNIT (IESU) FOR FAILURE ANALYSIS INVESTIGATION. THE UNIT WAS ANALYZED AND FOUND THAT THE REPORTED ISSUE OF INTERMITTENT TOWER FUNCTION AND MONOPOLAR NOT FIRING COULD NOT BE REPRODUCED. SYSTEM LOGS DID NOT CONFIRM A FIELD FAULT. VISUAL INSPECTION NOTED SCRATCHES ON THE TOP COVER. THE UNIT FUNCTIONED AS EXPECTED WHEN TESTED ON A GOLDEN SYSTEM. THE PROBABLE ROOT CAUSE IN THIS CASE CANNOT BE DETERMINED BASED ON THE FAILURE ANALYSIS. THIS ISSUE WAS RESOLVED BY REPLACING THE ERBE GENERATOR.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED CHOLECYSTECTOMY SURGICAL PROCEDURE THAT THE INTEGRATED ELECTROSURGICAL UNIT (IESU) CUTTING AND COAGULATION FUNCTIONS WERE INTERMITTENTLY WORKING. THERE WAS A RED QUESTION MARK NEXT TO THE MONOPOLAR ENERGY. THE CALLER WAS UNSURE IF THEIR SITE TRACKS THE ENERGY CABLE LIVES. THE INTUITIVE TECH SUPPORT ENGINEER (TSE) REVIEWED THE SYSTEM LOGS AND FOUND C-30, C-38, M-11, AND M-18 ERRORS. THE CALLER SWAPPED INSTRUMENTS, BUT THE ISSUE RETURNED INTERMITTENTLY. THE TSE RECOMMENDED REBOOTING THE ERBE OR TRYING A NEW ENERGY CABLE FOR THE MONOPOLAR ENERGY. THE CALLER STATED THAT THE ERBE WAS CURRENTLY WORKING CORRECTLY, AND THEY DID NOT WANT TO INTERRUPT THE SURGEON. THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL ERBE, WITH NO REPORTS OF PATIENT INJURY. INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE FOLLOWING ADDITIONAL INFORMATION VIA FOLLOW UP: THE ISSUE HAS BEEN RESOLVED. A NEW ERBE HAS BEEN BROUGHT IN TO REPLACE THE DEFECTIVE ONE.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1632523 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-41 N/A 00886874110898

    Patients

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