BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 25339151 · Received May 29, 2026

    Report

    Report Number
    2955842-2026-27001
    Event Type
    Malfunction
    Date Received
    May 29, 2026
    Date of Event
    May 8, 2026
    Report Date
    May 29, 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
    NY, US
    Reporter Occupation
    003

    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 THE ENDOSCOPE CONTROLLER (EC). THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI DID NOT RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED NEPHROURETERECTOMY SURGICAL PROCEDURE, THE CUSTOMER ATTEMPTED TO INSTALL TWO ENDOSCOPES, BUT THE SCREEN DID NOT RECOGNIZE THAT ANYTHING WAS CONNECTED. THE CUSTOMER THEN PERFORMED A HARD POWER CYCLE OF THE VISION SIDE TOWER, BUT THE ISSUE PERSISTED. TECHNICAL SERVICE ENGINEER REVIEWED THE SYSTEM LOGS AND DID NOT FIND ANY RELATED ISSUES. THE CUSTOMER SWAPPED THE VISION SIDE TOWER WITH ANOTHER VISION SIDE CART TO CONTINUE USE. THE PROCEDURE WAS CONVERTED TO ANOTHER DV SYSTEM WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    130761 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-17 N/A 00886874110898

    Patients

    Seq Age Sex Outcome Treatment
    1