BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 24851151 · Received April 11, 2026

    Report

    Report Number
    2955842-2026-21263
    Event Type
    Malfunction
    Date Received
    April 11, 2026
    Date of Event
    March 18, 2026
    Report Date
    May 12, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110744
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. THE FSE REPLACED MASTER TOOL MANIPULATOR (MTM) TO RESOLVE THE ISSUE. THE SYSTEM WAS VERIFIED AND READY TO USE. ISI HAS RECEIVED THE MTM FOR EVALUATION. HOWEVER, THE FAILURE ANALYSIS HAS NOT BEEN COMPLETED YET. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED. 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 DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE LEFT-HAND CONTROL HAD A SYSTEM MESSAGE. SITE PERFORMED A HARD REBOOT ON THE SYSTEM, BUT THE LEFT-HAND CONTROL ERROR PERSISTS. THE SYSTEM WAS STILL NOT CONNECTED TO ONSITE. SITE ELECTED TO DISCONNECT THE CONSOLE AND USE THE SYSTEM AS A SINGLE CONSOLE CONFIGURATION. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295154 DAVINCI XI SURGEON SIDE CONSOLE, SMART PEDALS NAY INTUITIVE SURGICAL, INC 380677-17 N/A 00886874110744

    Patients

    Seq Age Sex Outcome Treatment
    1