BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 23130067 · Received September 24, 2025

    Report

    Report Number
    2955842-2025-39163
    Event Type
    Malfunction
    Date Received
    September 24, 2025
    Date of Event
    September 2, 2025
    Report Date
    November 10, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    NURSE
    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 THE UNIVERSAL SURGICAL MANIPULATOR (USM). 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.

    Additional Manufacturer Narrative · 0

    DURING VISUAL INSPECTION NO EVIDENCE WAS FOUND THAT WOULD RELATED TO THE REPORTED PROBLEM. THE UNIT WAS TESTED ON AN IN-HOUSE SYSTEM AND FAILED IN NORMAL MODE (ERROR 31226-1126). THE UNIT WAS ALSO TESTED ON A PATIENT FIXTURE TEST PLATFORM (PFTP) AND FIBER TEST FAILED POINTING TO THE ROLLING LOOP AND PARALLELOGRAM. ONCE TESTING WAS COMPLETED, THE FIBERS WERE APPLIED BEHAVIORAL ANALYSIS (ABA) TESTED, AND IT WAS VERIFIED TO BE THE SOURCE OF THE FAULT. AS A RESULT OF THIS INVESTIGATION, FAILURE ANALYSIS WAS ABLE TO CONCLUDE THAT THE ROLLING LOOP ASSY AND PARALLELOGRAM ASSY WERE FOUND TO BE THE ROOT CAUSE OF THE REPORTED EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED UROLOGY PARTIAL NEPHRECTOMY SURGICAL PROCEDURE, THE CUSTOMER REPORTED TO TECHNICAL SERVICE ENGINEER (TSE) THAT UNIVERSAL SURGICAL MANIPULATOR (USM) ARM 1 WAS DISABLED DUE TO ERROR 32097 DISPLAYED. TSE VERIFIED PRESENCE OF ERROR IN LOGS AND RELATED ERRORS POINTING AT INTERNAL COMMUNICATION ERROR WITHIN USM 1. THE CUSTOMER RESTARTED SYSTEM; HOWEVER, THE ERROR PERSISTED. THE CUSTOMER CONFIRMED THEY CAN PROCEED AS 3 USM ARM 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
    541193 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-36 N/A

    Patients

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