BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 24566022 · Received March 11, 2026

    Report

    Report Number
    2955842-2026-15693
    Event Type
    Malfunction
    Date Received
    March 11, 2026
    Date of Event
    February 18, 2026
    Report Date
    March 10, 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
    TX, US
    Reporter Occupation
    NURSE
    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. FSE THE INTEGRATED ELECTROSURGICAL UNIT (IESU) OR ERBE DUE TO ERROR M-02-5. 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 UNIT WAS RETURNED FOR FAILURE ANALYSIS, AND THE REPORTED ISSUE WAS CONFIRMED USING SYSTEM LOGS, WHICH RECORDED MULTIPLE ERRORS. UPON VISUAL INSPECTION, AN ISSUE WAS IDENTIFIED THAT MAY BE RELATED TO THE REPORTED EVENT. DURING FUNCTIONAL TESTING, THE UNIT DISPLAYED ERROR CODE M-02-3 UPON STARTUP, AND A REVIEW OF THE ERBE INTERNAL LOG SHOWED ERRORS M-02 AND C-00. THE COMPLAINT WAS CONFIRMED BASED ON FIELD EVALUATION AND FAILURE ANALYSIS. THE PROBABLE ROOT CAUSE CANNOT BE DETERMINED BASED ON FAILURE ANALYSIS; HOWEVER, THE ROOT CAUSE IS LIKELY DUE TO A COMPONENT FAILURE WITHIN THE OPERATION OF THE ERBE. BLANK MDR FIELDS: THE MISSING PATIENT INFORMATION IN SECTIONS A AND B WAS EITHER UNKNOWN, UNAVAILABLE, NOT PROVIDED, OR NOT APPLICABLE. THE EXPIRATION DATE FOR SECTION D4 IS NOT APPLICABLE. FIELD D6 IS BLANK BECAUSE THE PRODUCT IS NOT IMPLANTABLE. FIELD E4 IS BLANK BECAUSE IT IS UNKNOWN IF THE INITIAL REPORTER SUBMITTED A REPORT TO THE FDA. FIELDS G5 AND G7 ARE NOT APPLICABLE. FIELD H10 IS BLANK AS THERE ARE NO RELATED REPORT NUMBERS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO STARTING A DA VINCI-ASSISTED SURGICAL PROCEDURE USING AN XI SYSTEM BEFORE SURGICAL PORTS PLACEMENT, THE CUSTOMER REPORTED THE INTEGRATED ELECTROSURGICAL UNIT (IESU) OR ERBE ERROR M-02-5. THE CUSTOMER POWER CYCLED AND RESET THE ERBE POWER CONNECTION SEVERAL TIMES, BUT THE ISSUE PERSISTED. THE ERBE UNIT REQUIRED REPLACEMENT. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) RECOMMENDED USING EITHER THE FORCE TRIAD OR E-200 GENERATOR AS ALTERNATIVES. THE CUSTOMER WAS ADVISED TO CALL BACK IF FURTHER GUIDANCE WAS NEEDED TO CONNECT THEIR E-200. ULTIMATELY, THE CUSTOMER SWITCHED TO ANOTHER XI SYSTEM TO CONTINUE THE PROCEDURE. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    454097 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-17 N/A 00886874110898

    Patients

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