BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 23376489 · Received October 24, 2025

    Report

    Report Number
    2955842-2025-42774
    Event Type
    Malfunction
    Date Received
    October 24, 2025
    Date of Event
    October 3, 2025
    Report Date
    April 28, 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
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. THE FSE REPLACED THE INTEGRATED ELECTROSURGICAL UNIT (IESU) TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI HAS RECEIVED THE IESU AND THE FA IS STILL IN PROGRESS. THE COMPLAINT WAS CONFIRMED BASED ON THE FIELD EVALUATION.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE ISSUE COULD NOT BE DIRECTLY CONFIRMED IN SYSTEM LOG REVIEW. SYSTEM LOG REVIEW IDENTIFIED SOME OTHER ERRORS SUCH AS M-02, 1-71, C-71, AND C-82 LOGGED ON DIFFERENT DATES. THE GENERATOR WAS ANALYZED AND FOUND THAT WHEN TESTED ON A SYSTEM, THE UNIT PRESENTED 1-71 AND M-02-3 STARTUP ERRORS. THE LOG REVIEW FURTHER IDENTIFIED M-02, C-00, M-32, M-B0, AND M-11 ERRORS ON THE GIVEN EVENT DATE. VISUAL INSPECTION IDENTIFIED HAIRLINE CRACKS ON THE FRONT BEZEL AT THE TOP AND BOTTOM LEFT CORNERS BETWEEN THE GREY AND WHITE SECTIONS. THE HOUSING COVER EXHIBITS SEVERAL MINOR SCRATCHES AND MAY REQUIRE FURTHER EVALUATION AND POTENTIAL REPLACEMENT. THE COMPLAINT WAS CONFIRMED BASED ON FIELD EVALUATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO STARTING A DA VINCI-ASSISTED BENIGN HYSTERECTOMY SURGICAL PROCEDURE, THE ERBE WILL NOT DETECT INSTRUMENT CORDS AND TRIED SEVERAL CORDS AND ,POWER CYCLED THE UNIT. SITE SWAPPED THE VSC FROM THEIR OTHER SYSTEM AND CONTINUED THE PROCEDURE. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    449012 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