BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 24694060 · Received March 25, 2026

    Report

    Report Number
    2955842-2026-18114
    Event Type
    Malfunction
    Date Received
    March 25, 2026
    Date of Event
    November 7, 2025
    Report Date
    March 25, 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
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. BASED ON THE FIELD EVALUATION, THIS REPORTED EVENT WAS CONFIRMED, WHICH INDICATES THAT THE DEVICE MAY HAVE CONTRIBUTED TO THE CUSTOMER REPORTED ISSUE. FSE REPLACED THE UNIVERSAL SURGICAL MANIPULATOR (USM). THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI DID RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. IN ARTEMIS, THE 32100 ERROR WAS FOUND. THE UNIT WAS INSTALLED ON AN IN-HOUSE SYSTEM WHERE THE 32100 ERROR WAS TRIGGERED, REPLICATING THE REPORTED EVENT. THE UNIT WAS THEN INSTALLED ON AN IN-HOUSE PATIENT SIDE CART (PSC) FIXTURE TEST PLATFORM (PFTP) WHERE THE UNIT FAILED FAULT CHECK WITH A 32100 ERROR IN THE LOGS. A GOLDEN ROLLING LOOP FLAT FLEX CABLE (FFC) WAS INSTALLED AND THE UNIT PASSED THE REQUIRED TEST, VERIFYING THAT THE ROLLING LOOP FFC TO BE THE SOURCE OF THE FAULT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO THE START - PRE-ANESTHESIA OF A DA VINCI-ASSISTED ENDOMETRIOSIS RESECTION SURGICAL PROCEDURE, CUSTOMER ENCOUNTERED A REPEATED RECOVERABLE ERROR 32100 ON ARM 1 AT STARTUP THAT WILL NOT RECOVER. SYSTEM LOGS CONFIRMED ERROR 32100 REPORTED BY UNIVERSAL SURGICAL MANIPULATOR (USM) 1 AXES CONTROLLER MOTOR (ACM). THE CUSTOMER PERFORMED A SYSTEM REBOOT, AS WELL AS A HARD REBOOT/EMERGENCY POWER OFF (EPO) ON THE PATIENT SIDE CART (PSC) WITH NO CHANGE. THE CUSTOMER CONFIRMED THAT THEY HAVE ANOTHER SYSTEM THAT IS NOT BEING USED, AND THEY WERE GOING TO BRING IN THEIR OTHER PSC FOR THE PROCEDURE. THE OTHER PSC POWERED ON SUCCESSFULLY WITH NO ERRORS. CUSTOMER IS CONTINUING WITH CASE SETUP. THE PROCEDURE WAS ABORTED TO ANOTHER DV SYSTEM WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    556359 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-47 00886874110720

    Patients

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