BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 24906714 · Received April 17, 2026

    Report

    Report Number
    2955842-2026-21873
    Event Type
    Malfunction
    Date Received
    April 17, 2026
    Date of Event
    March 18, 2026
    Report Date
    April 16, 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
    AU
    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 COMPLAINT. THE FSE WAS ABLE TO REPRODUCE THE ISSUE AND REPLACED THE VIO INTEGRATED ELECTROSURGICAL GENERATOR UNIT (IESU). THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. AS OF THE DATE OF THIS REPORT, THE IESU HAS NOT YET BEEN RECEIVED BY INTUITIVE SURGICAL, INC. (ISI) FOR EVALUATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SUBTOTAL COLECTOMY SURGICAL PROCEDURE, AN ERROR C34 OCCURRED ON THE ERBE GENERATOR WHEN ATTEMPTING TO USE THE MONOPOLAR FUNCTION. AN INTUITIVE SURGICAL (IS) TECHNICAL SUPPORT ENGINEER (TSE) WAS CONTACTED FOR TROUBLESHOOTING SUPPORT. THE NURSE HAD ALREADY REBOOTED THE ERBE AND REPLACED THE ENERGY CABLES. THE TSE CONFIRMED THE ERROR IN THE SYSTEM LOGS AND GUIDED THE NURSE TO SWITCH TO CLASSIC MODE AS A WORKAROUND. HOWEVER, THE SURGERY WAS AT A STAGE WHERE THE SURGEON COULD NOT IMMEDIATELY TEST IF THE WORKAROUND WAS EFFECTIVE. THE TSE INQUIRED ABOUT A BACKUP OPTION, WHICH WAS NOT AVAILABLE. THE NURSE WAS INSTRUCTED TO CALL BACK TO UPDATE ON WHETHER THE WORKAROUND WAS SUCCESSFUL OR IF THE SURGERY NEEDED TO BE CONVERTED. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204787 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-46 N/A 00886874110898

    Patients

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