BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 22502176 · Received July 14, 2025

    Report

    Report Number
    2955842-2025-29544
    Event Type
    Malfunction
    Date Received
    July 14, 2025
    Date of Event
    June 18, 2025
    Report Date
    June 18, 2025
    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
    OK, US
    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 COMPLAINT. FSE WAS NOT ABLE TO REPRODUCE THE REPORTED COMPLAINT, HOWEVER, THE FSE DID REPLACE THE DISTAL SET UP JOINT (SUJ). THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI DID RECEIVE THE DISTAL SUJ TO PERFORM FAILURE ANALYSIS (FA). FA WAS ABLE TO CONFIRM VIA SYSTEM LOGS BUT WAS NOT ABLE TO REPRODUCE THE REPORTED COMPLAINT DURING IN-HOUSE TESTING. UPON VISUAL INSPECTION, IT WAS OBSERVED THAT THE TOP CAP COVERING THE SETUP FRU LOWER (SFL) PRINTED CIRCUIT ASSEMBLY (PCA) BOARD WAS BROKEN BUT NOT RELATED TO THE REPORTED EVENT. THE UNIT WAS INSTALLED ONTO A GOLDEN SYSTEM AND THE UNIT STARTED UP IN NORMAL MODE WITH NO ERRORS TRIGGERED. THE UNIT WAS THEN INSTALLED ONTO A PATIENT SIDE CART FIXTURE TEST PLATFORM (PFTP) AND THE UNIT PASSED ALL APPLICABLE TEST WITH NO ERRORS. AS A RESULT OF THESE FINDINGS, FAILURE ANALYSIS WAS ABLE TO CONCLUDE THAT THE MOTOR MODULE AND AXES CONTROLLER TORNADO (ACT) BOARD ARE CONSISTENT WITH THE REPORTED PROBLEM AND COULD BE THE POTENTIAL ROOT CAUSES FOR THIS ISSUE. THE PROBABLE ROOT CAUSE IS LIKELY RELATED TO ELECTRICAL ISSUES FROM THE MOTOR MODULE AND THE ACT BOARD LOCATED WITHIN THE DISTAL SUJ. THIS ISSUE CAN BE RESOLVED BY REPLACING THE DISTAL SUJ.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE THAT ARM 3 WAS NON-RESPONSIVE SEVERAL TIMES. THE CUSTOMER CONTINUED THE PROCEDURE. THERE WERE NO REPORTS OF PATIENT INJURY. INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE CUSTOMER AND OBTAINED THE FOLLOWING INFORMATION: ARM 3 WAS DISABLED IN ORDER TO CONTINUE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1196354 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-44 N/A 00886874110720

    Patients

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