BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 8589294 · Received May 7, 2019

    Report

    Report Number
    2955842-2019-10333
    Event Type
    Malfunction
    Date Received
    May 7, 2019
    Date of Event
    April 12, 2019
    Report Date
    April 12, 2019
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K131861
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION CAN BE FOUND IN THE FOLLOWING SECTIONS: DATE OF REPORT, CONCOMITANT MEDICAL PRODUCTS , PMA/510K, AND IF FOLLOW-UP, WHAT TYPE. (B)(4) - INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE MASTER TOOL MANIPULATOR (MTM) ASSOCIATED WITH THIS COMPLAINT AND COMPLETED ITS INVESTIGATION. FAILURE ANALYSIS (FA) REPRODUCED THE REPORTED ISSUE (ERROR 1) DURING CALIBRATION TEST. AS A FIX THE EMBEDDED SERIALIZER IN MASTER BASE (ESMB) PRINTED CIRCUIT ASSEMBLY (PCA) WILL BE REPLACED TO ADDRESS THE ISSUE.

    Description of Event or Problem · 0

    REFER TO ADDITIONAL FOR FOLLOW-UP INFORMATION.

    Additional Manufacturer Narrative · 1

    ISI RECEIVED THE MASTER TOOL MANIPULATOR (MTM) FOR FAILURE ANALYSIS, HOWEVER, THE EVALUATION IS STILL IN PROGRESS. THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE HAS NOT BEEN DETERMINED. A FOLLOW UP MDR WILL BE SUBMITTED ONCE THE FAILURE ANALYSIS EVALUATION HAS BEEN COMPLETED AND/OR IF ADDITIONAL INFORMATION IS RECEIVED. THE COMPLAINT IS BEING REPORTED DUE TO A DA VINCI SYSTEM MALFUNCTION RENDERING THE DA VINCI SYSTEM UNAVAILABLE FOR USE AFTER THE START OF A SURGICAL PROCEDURE. ALTHOUGH NO PATIENT HARM OCCURRED, IF THE REPORTED MALFUNCTION WERE TO RECUR, IT COULD CAUSE OR IT COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO STARTING A DA VINCI-ASSISTED INGUINAL HERNIA REPAIR SURGICAL PROCEDURE, THE SYSTEM REFLECTED AN ERROR ONE MESSAGE POINTING TO THE RIGHT MASTER TOOL MANIPULATOR ON THE SURGEON SIDE CONSOLE (SSC). AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) WALKED THE CLINICAL SALES REPRESENTATIVE (CSR) THROUGH HARD CYCLING THE SSC MULTIPLE TIMES AND THE FAULT KEPT RETURNING. AS SUCH, THE PROCEDURE WAS CONVERTED TO OPEN SURGERY. THERE WAS NO HARM TO THE PATIENT. ISI COMPLETED FOLLOW UP WITH ISI REPRESENTATIVE WHO CONFIRMED THAT TROUBLESHOOTING COULD NOT BE PERFORMED ON THE RIGHT MASTER TOOL MANIPULATOR. THE PROCEDURE WAS CONVERTED TO OPEN SURGERY AND COMPLETED WITH NO REPORTED INJURY TO THE PATIENT. THE CUSTOMER DOES NOT KNOW THE CAUSE OF THE ISSUE AND THE SYSTEM WAS INSPECTED PRIOR TO USE. AN ISI FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED COMPLAINT. FSE WAS ABLE TO REPLICATE THE REPORTED ERROR UPON START UP. FSE FOUND THE SYSTEM POWER FAULT ERROR 1 MULTIPLE TIMES IN THE LOGS. FSE REPLACED THE RIGHT MASTER TOOL MANIPULATOR (MTMR) TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    381849 DAVINCI XI SURGEON SIDE CONSOLE, SMART PEDALS NAY INTUITIVE SURGICAL, INC 380677-16

    Patients

    Seq Age Sex Outcome Treatment
    1 DA VINCI INSTRUMENTS AND ACCESSORIES