BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 25143957 · Received May 11, 2026

    Report

    Report Number
    2955842-2026-24616
    Event Type
    Malfunction
    Date Received
    May 11, 2026
    Date of Event
    April 14, 2026
    Report Date
    May 11, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110720
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    BIOMEDICAL ENGINEER
    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 COMPLAINT. THE FSE WAS ABLE TO REPRODUCE THE ISSUE AND REPLACED THE UNIVERSAL SURGICAL MANIPULATOR (USM). THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. THE USM INVOLVED WITH THIS EVENT HAS BEEN RECEIVED, BUT THE FAILURE ANALYSIS TESTING HAS NOT YET BEEN COMPLETED AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER A DA VINCI-ASSISTED HIGH ANTERIOR RESECTION SURGICAL PROCEDURE, THE CUSTOMER EXPERIENCED ERROR 32056 WHEN STARTING UP THE PATIENT SIDE CART IN STANDALONE MODE. AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SERVICE ENGINEER (TSE) REVIEWED THE ERROR AND DETERMINED THAT ERROR 32056 INDICATED A PROBLEM WITH THE UNIVERSAL SURGICAL MANIPULATOR (USM) 1 AXES CONTROLLER ARM (ACA) AND NOTED THAT THE ERROR PERSISTED EVEN AFTER A HARD POWER CYCLE WAS PERFORMED. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. ISI CONTACTED THE ISI FIELD SERVICE ENGINEER AND OBTAINED THE FOLLOWING INFORMATION: THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434569 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-46 N/A 00886874110720

    Patients

    Seq Age Sex Outcome Treatment
    1