BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 21660734 · Received March 21, 2025

    Report

    Report Number
    2955842-2025-10182
    Event Type
    Malfunction
    Date Received
    March 21, 2025
    Date of Event
    February 25, 2025
    Report Date
    February 25, 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
    AZ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE UNIVERSAL SURGICAL MANIPULATOR HAS BEEN EVALUATED BY THE FAILURE ANALYSIS (FA) TEAM. FA WAS ABLE TO CONFIRM AND REPRODUCE THE REPORTED COMPLAINT DURING IN-HOUSE TESTING. UNIT WAS TESTED ON AN IN-HOUSE SYSTEM IN NORMAL MODE WITH NO TRIGGERED ERRORS. UNIT WAS ALSO TESTED ON A PATIENT SIDE CART FIXTURE TEST PLATFORM (PFTP) WHERE IT FAILED CARRIAGE SWITCHES. ABA TROUBLESHOOTING WAS PERFORMED WHERE THE GOLD AXES CONTROLLER, CARRIAGE POWER (ACCP), AXES CONTROLLER, CARRIAGE LOGIC (ACCL), AXES CONTROLLER, CARRIAGE, INSTRUMENT (ACCI), AND AXES CONTROLLER, CARRIAGE RFID (ACCR) WAS NEEDED TO PASS TEST. NO SIGNS OF VISUAL DAMAGE DURING INSPECTION. THE ACCP, ACCL, ACCI, AND ACCR WAS FOUND TO BE THE ROOT CAUSE OF THE REPORTED EVENT.

    Additional Manufacturer Narrative · 0

    THE PROBABLE ROOT CAUSE OF THE REPORTED COMPLAINT CAN BE ATTRIBUTED TO A COMPONENT FAULT ON THE AXES CONTROLLER ASSEMBLY WITHIN THE AFFECTED UNIVERSAL SURGICAL MANIPULATOR.

    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 REPLACED THE UNIVERSAL SURGICAL MANIPULATOR TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. THE IESU 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

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER WAS STATING THE ISSUE THEY HAD PREVIOUSLY HAS RETURNED. ARM 4 WAS NOT RECOGNIZING ANY INSTRUMENTS. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE PROCEDURE WAS ORIGINALLY A 3 ARM PROCEDURE AS THEY PLANNED TO STOW ARM 1, HOWEVER ARM 4 WAS NOT FUNCTIONING AS NEEDED. IT WAS NOT ACCEPTING THE INSTRUMENT THEREFORE THEY CONTINUED THE PROCEDURE WITH ARMS 1,2, AND 3. AFTER THE PROCEDURE, THEY RESEATED THE DRAPE AND RESTARTED THE SYSTEM AND WAS ABLE TO CONTINUE USING ARM 4 FOR THE NEXT PROCEDURE HOWEVER THE ISSUE HAPPENED AGAIN. THE TECHNICIAN WENT OUT AND REPLACED THE ARM DUE TO THE ISSUE. SINCE THEN, THERE HAVE NOT BEEN ANY OTHER ISSUES. NO PATIENT DEMOGRAPHICS OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1308222 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-56 N/A 00886874110720

    Patients

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