BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 24480232 · Received March 2, 2026

    Report

    Report Number
    2955842-2026-14710
    Event Type
    Malfunction
    Date Received
    March 2, 2026
    Date of Event
    January 30, 2026
    Report Date
    March 13, 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
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. CUSTOMER REPORTED M-02 ERRORS ON THE ERBE. THE CASE WAS CONVERTED TO OPEN FOR A NON-ROBOTIC REASON, AND AN FSE LATER VISITED THE SITE AND REPLACED THE ERBE GENERATOR DUE TO THE REPORTED ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI DID RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE ERBE GENERATOR WAS ANALYZED AND FOUND ISSUE WAS CONFIRMED USING SYSTEM LOGS WITH RECURRING C-82, I-71, AND M-02 ERRORS. DURING TESTING, THE ERBE DISPLAYED I-87 FOLLOWED BY M-02-3 ON STARTUP, AND INTERNAL LOGS ALSO RECORDED C-00 AND M-02 ERRORS. THE ERBE UNIT WILL BE SENT TO THE ORIGINAL EQUIPMENT MANUFACTURER FOR FURTHER ANALYSIS. THE COMPLAINT WAS CONFIRMED BASED ON THE FIELD EVALUATION, WHICH INDICATES THAT THE DEVICE MAY HAVE CONTRIBUTED TO THE CUSTOMER REPORTED ISSUE. 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. THIS ISSUE IS CAPTURED IN THE IS4000 FAMILY SHARED CLINICAL RISK ANALYSIS (818001-45 REV AU) VIA RISK ID G4-SYS-70289.

    Additional Manufacturer Narrative · 0

    AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) CONFIRMED THE REPORTED PROBLEM AS THERE WAS AN INTERMITTENT ERROR ON THE INTEGRATED ELECTROSURGICAL UNIT (IESU). THE FSE REPLACED THE INTEGRATED ELECTROSURGICAL UNIT (IESU) TO ADDRESS THE FAILURE. THE IESU WAS RECEIVED FOR FAILURE ANALYSIS TESTING. VISUAL INSPECTION IDENTIFIED SCRATCHES AND TOUCH UP PAINT ON COVERING/HOUSING OF THE UNIT. ALONG WITH NOTICEABLE SCRATCHES ON THE GREY BEZEI. THE IESU STARTED UP WITH ERRORS AND A LOG REVIEW OF THE UNIT IDENTIFIED ADDITIONAL FAULTS.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO STARTING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER EXPERIENCED AN ERBE ERROR (M-02). AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE SITE TO INVESTIGATE THE REPORTED PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171377 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.