BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 20956109 · Received December 17, 2024

    Report

    Report Number
    2955842-2024-23293
    Event Type
    Malfunction
    Date Received
    December 17, 2024
    Date of Event
    November 22, 2024
    Report Date
    November 22, 2024
    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
    WI, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REMOTE ARM CONTROLLER (RAC) BOARD WAS INSTALLED ONTO A SURGEON SIDE CONSOLE TEST SYSTEM AND COMPLETED PROGRAM AND STARTUP WITH NO ISSUE. THE RAC WAS RUN FOR TEN POWER CYCLES AND SAT IDLE WITH NO PROBLEM. ERROR 23 COULD NOT BE REPLICATED. ARM TEST DRIVE ALSO WORKED. THE RAC NEEDED TO BE REPROGRAMMED AT THE BENCH STATION FOR POWER CYCLE AND ADDITIONAL TESTING. THERE WERE NO ISSUES IDENTIFIED DURING VISUAL INSPECTION. THE FIRST MASTER TOOL MANIPULATORS (MTM) WAS RETURNED FOR FAILURE ANALYSIS AND THE REPORTED 30 ERROR WAS CONFIRMED BUT NOT REPLICATED. IN THE LOGS, THE 30 ERROR WAS FOUND POINTING TO THE EMBEDDED SERIALIZER MASTER BOARD (ESMB), CONFIRMING THE FAULT OCCURRED IN THE FIELD. UPON VISUAL INSPECTION, NO ISSUES WERE FOUND THAT WOULD BE RELATED TO THE REPORTED EVENT. THE MTM WAS THEN INSTALLED ONTO A PATIENT FIXTURE TEST PLATFORM (PFTP) WHERE ALL RELEVANT TESTING PASSED WITHIN SPECIFICATION. ONCE TESTING WAS COMPLETED, THE ESMB AND MWH COMPONENT WAS INSPECTED, AND NO FAULTS COULD BE IDENTIFIED. AS A RESULT OF THESE FINDINGS, FAILURE ANALYSIS CONCLUDED THAT THE ESMB AND MWH ARE CONSISTENT WITH THE REPORTED EVENT AND ARE THE POTENTIAL ROOT CAUSE FOR THIS ISSUE. THE PROBABLE ROOT CAUSE IS ATTRIBUTED TO A DEFECTIVE RAC. THE RAC TRIGGERED ERROR 35 PREVENTING THE SYSTEM TO COMPLETE STARTUP.

    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 REMOTE ARM CONTROLLER (RAC) BOARDS AND RAN SINE CYCLE TESTS ON THE MASTER TOOL MANIPULATORS (MTM). THE FSE ALSO REPLACED BOTH MTMS. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI DID RECEIVE THE FIRST RAC BOARD INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. HOWEVER, FAILURE ANALYSIS IS NOT COMPLETE. ISI RECEIVED A SECOND RAC BOARD AND COMPLETED FAILURE ANALYSIS. THE RAC WAS INSTALLED ON THE PRINTED CIRCUIT ASSEMBLY (PCA) SYSTEM AND COULD NOT GO THROUGH THE PROGRAM PROCESS. ERROR 35 APPEARED AFTER BOOTING UP. ERROR 35 INDICATED THAT THE SYSTEM STARTED BUT COULD NOT COMPLETE THE INITIALIZATION. THE FIRST MTM WAS RECEIVED BUT FAILURE ANALYSIS IS NOT COMPLETE. THE SECOND MTM HAS NOT BEEN RECEIVED.

    Additional Manufacturer Narrative · 0

    THE MTM WAS ANALYZED AND THE COMPLAINT WAS CONFIRMED BY FA. IN ARTEMIS, THE NON-RECOVERABLE FAULT AND RETURNING TO HOME POSITION WITHOUT ANY USER WAS FOUND DURING CALIBRATION. UPON VISUAL INSPECTION, NO ISSUES WERE FOUND THAT WOULD BE RELATED TO THE REPORTED EVENT. THE MTM WAS THEN INSTALLED ONTO A PFTP WHERE CALIBRATION WAS DONE, AND UNIT WAS RETAINING HOMING POSITION AND RECOVERABLE FAULT WAS GONE AFTER CALIBRATION. ONCE TESTING WAS COMPLETED, THE MTM WAS TESTED AND WAS VERIFIED TO BE THE SOURCE OF THE FAULT.

    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 SLIDING HIATAL HERNIA SURGICAL PROCEDURE, THE CUSTOMER REPORTED TO THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) ABOUT A NON-RECOVERABLE 41010 FAULT. THE SYSTEM LOGS SHOWED THE 23/30 ERRORS POINTING TO AN ISSUE WITH THE LEFT MASTER TOOL MANIPULATOR (MTM) AND BLUE FIBER CABLE CONNECTION. AFTER SEVERAL HARD RESTARTS, THE CUSTOMER WAS ABLE TO CLEAR THE ERROR. HOWEVER, THE CUSTOMER CALLED BACK TO REPORT THAT THE ISSUE RETURNED. THE CUSTOMER REMOVED AN INSTRUMENT THAT WAS STUCK ON TISSUE AND CONVERTED TO LAPAROSCOPIC SURGERY. THERE WAS 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
    1486435 DAVINCI XI SURGEON SIDE CONSOLE, SMART PEDALS NAY INTUITIVE SURGICAL, INC 380677-16 N/A

    Patients

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