BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 23924911 · Received December 30, 2025

    Report

    Report Number
    2955842-2025-49903
    Event Type
    Malfunction
    Date Received
    December 30, 2025
    Date of Event
    December 10, 2025
    Report Date
    January 8, 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
    IL, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE THE INTEGRATED ELECTROSURGICAL UNIT (IESU) ERBE TO PERFORM FAILURE ANALYSIS. THE COMPONENT WAS ANALYZED AND IT WAS FOUND TO HAVE FOLLOWING ERRORS ON SYSTEM LOGS: M-02 , 4-87 , 2-8A AND M-18. THE UNIT WAS TESTED ON THE SYSTEM WHERE IT PRESENTED ERROR(S) M-02-3/M-02 ON STARTUP FOLLOWED BY M-02, M-18 ERRORS IN THE SYSTEM LOGS. THE PROBABLE ROOT CAUSE OF ERROR M-02 IS ATTRIBUTED TO A FAULTY COMPONENT OF THE ERBE GENERATOR. M-02 ERRORS INDICATE A MODULE TIMEOUT ISSUE AND, THEREFORE, THE ACTIVATION WAS INTERRUPTED. THIS ERROR CAN BE RESOLVED AFTER POWER CYCLING THE GENERATOR AND/OR CHECKING THE CABLE CONNECTION TO THE SYSTEM. IN SOME CASES, THE AFFECTED COMPONENT MAY NEED TO BE REPLACED TO RESOLVE THE REPORTED ERROR.

    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 REPLACED THE INTEGRATED ELECTROSURGICAL UNIT (IESU) ERBE TO RESOLVE THE REPORTED ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. THE ERBE INVOLVED IN THIS COMPLAINT HAS NOT BEEN RECEIVED AND/OR TESTED BY FAILURE ANALYSIS AS OF THE DATE OF THIS REPORT. IF THE PRODUCT IS RECEIVED AND EVALUATED, A SUPPLEMENTAL MDR WILL BE SUBMITTED.

    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 MONOPOLAR SETTINGS HAD GRAYED OUT ON THE INTEGRATED ELECTROSURGICAL UNIT (IESU) ERBE GENERATOR. AN INTUITIVE SURGICAL INC., (ISI) TECHNICAL SUPPORT ENGINEER (TSE) REVIEWED THE SYSTEM LOGS AND NOTED ERROR M-02. PRIOR TO CALLING IN THE TSE, CUSTOMER TRIED REBOOTING THE ERBE. TSE HAD CUSTOMER HARD REBOOT THE ERBE BUT, WITH NO CHANGE. THE ERBE CONTINUED TO FAULT. CUSTOMER DID NOT HAVE A BACKUP GENERATOR OR VISION SIDE CART (VSC) AND IT WAS UNKNOWN HOW THEY WERE CONTINUING WITH THE PROCEDURE. THERE WERE NO REPORTS OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2220351 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-19 N/A 00886874110898

    Patients

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