BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 24478715 · Received March 2, 2026

    Report

    Report Number
    2955842-2026-14666
    Event Type
    Malfunction
    Date Received
    March 2, 2026
    Date of Event
    January 28, 2026
    Report Date
    March 17, 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

    AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED PROBLEM AND REPLACED THE ERBE INTEGRATED ELECTRO SURGICAL UNIT (IESU). THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI DID RECEIVE THE DA VINCI PRODUCT INVOLVE WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. DURING VISUAL INSPECTION, SCRATCHES AND VISIBLE TOUCH UP PAINT WERE OBSERVED ON THE COVERING, ALONG WITH NOTICEABLE DENTS ON THE GREY BEZEL. THE REPORTED PROBLEM WAS CONFIRMED USING SYSTEM ERROR LOGS, AND C33 ERRORS WERE LOGGED ALONG WITH M36 ERRORS. DURING TESTING, THE ERBE UNIT DISPLAYED ERROR C33 UPON STARTUP. THE PROBABLE ROOT CAUSE COULD NOT BE ESTABLISHED.

    Additional Manufacturer Narrative · 0

    UPDATED: FROM C13 - OPERATIONAL PROBLEM IDENTIFIED TO C0201 - ELECTRICAL/ELECTRONIC COMPONENT PROBLEM IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED SACROCOLPOPEXY WITH HYSTERECTOMY SURGICAL PROCEDURE, PRIOR TO PORT PLACEMENT THAT THE CUSTOMER INITIALLY EXPERIENCED AN ERROR C-00 WITH THE ERBE, WHICH INTERRUPTED ACTIVATION AND PERSISTED AFTER A POWER CYCLE. THE CUSTOMER WAS UNCERTAIN ABOUT HAVING THE CORRECT CABLE. LATER, THE CUSTOMER CALLED BACK WITH TROUBLE CONNECTING THE FORCE TRIAD TO THE SYSTEM, BUT AFTER INSTALLING AN ENDOSCOPE, THE ENERGY DEVICE BECAME FUNCTIONAL. THE TECHNICAL SERVICE ENGINEER REVIEWED THE SYSTEM LOGS WHICH INDICATED A C-33 ERROR ON THE ERBE, SUGGESTING AN INTERNAL BURNED-OUT DIODE. THE PROCEDURE WAS COMPLETING AS PLANNED.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    287090 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-40 N/A 00886874110898

    Patients

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