BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 23813382 · Received December 16, 2025

    Report

    Report Number
    2955842-2025-48673
    Event Type
    Malfunction
    Date Received
    December 16, 2025
    Date of Event
    November 25, 2025
    Report Date
    December 24, 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
    AZ, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE INTEGRATED ELECTROSURGICAL UNIT (IESU) ERBE TO PERFORM FAILURE ANALYSIS. FAILURE ANALYSIS INVESTIGATIONS CONFIRMED THE CUSTOMER REPORTED COMPLAINT. THE UNIT WAS ANALYZED AND FOUND TO HAVE ERRORS C30, M11, AND C38. A VISUAL INSPECTION REVEALED A CONDITION THAT MAY BE RELATED TO THE ACTIVATION FAULT. SYSTEM TESTING SHOWED THAT ERROR C38 OCCURS WHILE FIRING THROUGH MONOPOLAR PORT 2. OTHER ERBE ERRORS WERE OBSERVED AS WELL. THE PROBABLE ROOT CAUSE OF THE REPORTED ERRORS IS ATTRIBUTED TO AN INTERNAL ELECTRICAL OR ELECTRONIC COMPONENT MALFUNCTION WITHIN THE ERBE. THE OBSERVED ERRORS INDICATE ABNORMAL VOLTAGE AND CURRENT MEASUREMENTS DURING ENERGY ACTIVATION, AS WELL AS INTERNAL MODULE TIMING DELAYS DURING STATE TRANSITIONS.

    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 POWERED ON THE SYSTEM AND PERFORMED A TEST DRIVE. THE SYSTEM DID NOT GENERATE ANY ERRORS DURING INSPECTION. FSE ATTEMPTED MULTIPLE TIMES TO REPLICATE THE ERROR BUT WITH NO SUCCESS. FSE REPLACED THE INTEGRATED ELECTROSURGICAL UNIT (IESU) ERBE AS A PRECAUTION TO RESOLVE THE REPORTED ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE ERBE GENERATOR; HOWEVER, FAILURE ANALYSIS INVESTIGATIONS ARE UNDER PROGRESS. ADDITIONAL INFORMATION IS BEING GATHERED TO DETERMINE THE CONTRIBUTION OF THE DEVICE TO THE CUSTOMER REPORTED ISSUE.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI ASSISTED SURGICAL PROCEDURE, THE INTEGRATED ELECTROSURGICAL UNIT (IESU) ERBE WAS FAULTING WITH MULTIPLE ERRORS WHILE FIRING MONOPOLAR ENERGY. IT PRESENTED A MESSAGE STATING THAT ACTIVATION HAD HALTED. CUSTOMER ELECTED NOT TO TROUBLESHOOT AT THE TIME AND CONTINUED WITH THE CASE. AN INTUITIVE SURGICAL INC., (ISI) TECHNICAL SUPPORT ENGINEER (TSE) REVIEWED THE SYSTEM LOGS AND NOTED ERROR(S) C-38 AND M-11. CUSTOMER FURTHER STATED THAT THEY COULD SEE ERROR C-34 AS WELL. CUSTOMER TRIED SWAPPING OUT MONOPOLAR ENERGY CORDS BUT THE ISSUE REMAINED. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2445393 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-36 N/A 00886874110898

    Patients

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