BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 17067764 · Received June 6, 2023

    Report

    Report Number
    2955842-2023-15876
    Event Type
    Malfunction
    Date Received
    June 6, 2023
    Date of Event
    May 8, 2020
    Report Date
    May 8, 2020
    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
    AR, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED COMPLAINT. THE FSE REPLACED THE TOUCHPAD ON THE SURGEON SIDE CONSOLE (SSC) DUE TO THE IMAGE WAS OFFSET 2 INCHES TO THE RIGHT. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE PART INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS INVESTIGATIONS COULD NOT REPLICATE THE REPORTED FAILURE. THE UNIT WAS INSTALLED ON AN XI SURGEON SIDE CONSOLE SYSTEM. THE COMPACT FLASH CARD WAS PROGRAMMED AND THE UNIT CALIBRATED WITH NO ISSUES. THE TOUCHSCREEN WAS FULLY RESPONSIVE WHILE NAVIGATING THROUGH THE USER INTERFACE. THE SCREEN WAS PERFECTLY CENTERED AND THERE WAS NO SIGN OF AN OFFSET. THE UNIT WAS RAN IN NORMAL MODE FOR TWO HOURS WITH NO ISSUES. THE UNIT WAS LEFT ON THE SYSTEM FOR TWO DAYS (ROUGHLY 60 POWER CYCLES) AND NO RELATED ERRORS WERE GENERATED IN THE SYSTEM LOGS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PROSTATECTOMY SURGICAL PROCEDURE, THE TOUCHPAD ON THE SURGEON SIDE CONSOLE (SSC) HAD SHIFTED OVER. THE SITE HAD RESTARTED THE SYSTEM WITH NO CHANGE. THE TECHNICAL SUPPORT ENGINEER (TSE) HAD THE SITE PERFORM A HARD RESTART OF THE SYSTEM BUT THE ISSUE PERSISTED. THE SITE DECIDED TO SWAP OUT THE SSC AND CONTINUE WITH THE PROCEDURE. THE PROCEDURE WAS CONVERTED TO ANOTHER DA VINCI SURGICAL SYSTEM WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: THE SYSTEM WAS INSPECTED PRIOR TO USE. THE SITE HAD COMPLETED A CASE PRIOR AND THERE WAS NOTHING WRONG WITH THE SYSTEM. AN ERROR OCCURRED ON THE SAME SSC WHILE TROUBLESHOOTING THE TOUCHPAD ISSUE. THE SITE BROUGHT IN ANOTHER SSC AND CONTINUED WITH THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO PATIENT HARM. THE CUSTOMER WAS NOT ABLE TO PROVIDE INFORMATION ABOUT THE PATIENT'S MEDICAL HISTORY NOR THE PATIENT DEMOGRAPHIC INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1020483 DAVINCI XI SURGEON SIDE CONSOLE, SMART PEDALS NAY INTUITIVE SURGICAL, INC 380677-03 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Male DA VINCI INSTRUMENTS AND ACCESSORIES