BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 24735995 · Received March 30, 2026

    Report

    Report Number
    2955842-2026-19830
    Event Type
    Malfunction
    Date Received
    March 30, 2026
    Date of Event
    September 12, 2025
    Report Date
    May 4, 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
    SW
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ISI DID RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE UNIVERSAL SURGICAL MANIPULATOR (USM) WAS ANALYZED. FAILURE ANALYSIS CONFIRMED AND REPLICATED THE REPORTED COMPLAINT. ERROR 32056 WAS FOUND UPON REVIEWING LOGS INDICATING AXES CONTROLLER, ARM (ACA) ISSUE ON UNIVERSAL SURGICAL MANIPULATOR (USM) 4 AXIS. UPON VISUAL INSPECTION, NO ISSUES WERE FOUND THAT WOULD BE RELATED TO THE REPORTED EVENT. THE USM WAS INSTALLED ONTO AN IN-HOUSE SYSTEM WHERE IT FAILED A TEST ON THE ¿0X1¿ AXIS. THE COMPLAINT WAS CONFIRMED BASED ON FAILURE ANALYSIS, WHICH INDICATES THAT THE DEVICE MAY HAVE CONTRIBUTED TO THE CUSTOMER REPORTED ISSUE. THE PROBABLE ROOT CAUSE IS ATTRIBUTED TO COMMUNICATION ERRORS ON YAW SEARCHLIGHT FLAT FLEX CABLE (FFC). IT CAN BE RESOLVED BY REPLACING USM.

    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 UNIVERSAL SURGICAL MANIPULATOR (USM) 4 DUE TO PERSISTENT ERROR 32056. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ADDITIONAL INFORMATION IS BEING GATHERED TO DETERMINE THE CONTRIBUTION OF THE DEVICE TO THE CUSTOMER REPORTED ISSUE.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED SIMPLE EXTRAPERITONEAL PROSTATECTOMY SURGICAL PROCEDURE, PRIOR TO ADMINISTRATION OF ANESTHESIA AND PRIOR TO FIRST PORT PLACEMENT, AN ISSUE OCCURRED WITH UNIVERSAL SURGICAL MANIPULATOR (USM) 4 DISPLAYING A PERSISTENT ERROR 32056 IMMEDIATELY AFTER STARTUP. THE CUSTOMER INFORMED INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) THAT THE PATIENT HAD BEEN MOVED TO ANOTHER DA VINCI SYSTEM IN A DIFFERENT THEATER, ALLOWING THE PROCEDURE TO CONTINUE WITH THE OTHER SYSTEM. THE TSE VERIFIED THE PRESENCE OF ERROR 32056 AND OTHER RELATED ERRORS IN THE LOGS, WHICH INDICATED A PROBLEM WITH THE ENCODER IN USM 4, AXIS 1 AS REPORTED BY THE AXES CONTROLLER, ARM (ACA) BOARD. THE TSE GUIDED THE CUSTOMER THROUGH A HARD POWER CYCLE AND EMERGENCY POWER OFF (EPO) OF THE PATIENT SIDE CART (PSC), BUT THE FAULT PERSISTED. THE PROCEDURE WAS ABORTED TO ANOTHER DV SYSTEM WITH NO REPORTS OF PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267376 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-50 N/A 00886874110720

    Patients

    Seq Age Sex Outcome Treatment
    1