BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 21046576 · Received December 31, 2024

    Report

    Report Number
    2955842-2024-23841
    Event Type
    Malfunction
    Date Received
    December 31, 2024
    Date of Event
    December 5, 2024
    Report Date
    December 5, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110898
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL INC. (ISI) RECEIVED THE GUIDED CAMERA CHANGE (GCC), GENERIC POWER DISTRIBUTOR (GPD) AND THE SURGEON BACK PLANE (SBP) FOR FAILURE ANALYSIS INVESTIGATION. THE UNIT WAS ANALYZED, AND IN REMOTE FE AND ARTEMIS, NO ERROR REPORTED. VISUAL INSPECTION, NO ISSUES WERE FOUND THAT IS RELATED TO THE REPORT ISSUE. THE GCC AND GPD WERE INSTALLED ON TO IS4000 SYSTEM WHERE THE COMPONENT FUNCTIONED AS EXPECTED. SSC FAILED BOOT UP AT START. BUTTON SWITCH WAS PURPLE AND GCC DID NOT COMMUNICATE WITH SYSTEM. REMOVED GPD BOARD OUT OF SYSTEM. INSTALLED GOLD GPD INTO SYSTEM TO TEST SSC STILL FAILED BOOT UP AT START. ONCE TESTING WAS COMPLETED, THE SYSTEM ERROR LOGS WAS INSPECTED. AS A RESULT OF THESE FINDINGS FAILURE ANALYSIS WAS ABLE TO CONCLUDE THE GCC BOARD TO BE THE ROOT CAUSE OF ON THE REPORTED EVENT. VISUAL INSPECTION: UNIT RETURNED IN GOOD CONDITION. SBP: IN REMOTE, NO DATA WAS FOUND TO INDICATE THAT THE FAULT HAD OCCURRED IN THE FIELD. VISUAL INSPECTION, NO ISSUES WERE FOUND THAT IS RELATED TO THE REPORT ISSUE. THE SBP WAS INSTALLED ONTO A GOLDEN SYSTEM (IS4000) WHERE THE COMPONENT FUNCTIONED AS EXPECTED. THEN THE GOLDEN SYSTEM WAS SET TO RU VIDEO TEST, PORTS CHECKED, 10 POWER CYCLES & SITTING IDLE FOR 1 HOUR. ONCE THE TESTING WAS COMPLETED, THE SYSTEM ERROR LOGS WERE INSPECTED, BUT NO ERROR COULD BE IDENTIFIED.

    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 REDUNDANT MEDICAL GRADE POWER SUPPLY (MGPS), GUIDED CAMERA CHANGE (GCC), GENERIC POWER DISTRIBUTOR (GPD) AND SURGEON BACK PLANE (SBP). INTUITIVE SURGICAL INC. (ISI) RECEIVED THE RMGPS FOR FAILURE ANALYSIS INVESTIGATION. THE UNIT WAS ANALYZED, AND THE POWER SUPPLY WAS INSTALLED ONTO AN SSC TEST SYSTEM COMPLETED PROGRAM AND START UP NO PROBLEM, CONTINUED WHERE IT RAN 10X POWER CYCLE AND IT SAT IDLE FOR ONE HOUR GOOD, SO FAR UNABLE TO REPLICATE THE REPORTED. HOWEVER, THIS POWER SUPPLY IS OLD VERSION, IT WILL BE SCRAPPED.

    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 GENERAL SURGICAL PROCEDURE, THE CUSTOMER REPORTED TO TECHNICAL SERVICE ENGINEER (TSE) THAT THE SURGEON SIDE CONSOLE (SSC) WAS NOT WORKING. PRIOR TO CALLING THE CUSTOMER HAS POWER OFF SYSTEM AND NOTED THE SSC POWER BUTTON HAS NO BACKLIGHT. THE ONSITE LOGS WERE NOT AVAILABLE. TSE WALKED THE CUSTOMER TO CYCLE SSC AC BREAKER TO THE DOWN POSITION FOR 15+ SECONDS WITH NO CHANGE. TSE WALKED THE CUSTOMER TO MOVE AC POWER CORD TO A DIFFERENT, KNOWN GOOD, AC OUTLET WITH NO CHANGE. TSE WALKED THE CUSTOMER TO PRESS SSC POWER BUTTON (TO RULE OUT POSSIBLY FAILED SSC POWER BUTTON BACKLIGHT FAILURE) WITH NO CHANGE. THE CUSTOMER WAS SWAPPING SSC TO PROCEED WITH CASE. THE PROCEDURE WAS CONVERTED TO ANOTHER DV SYSTEM WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1116249 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-31 N/A 00886874110898

    Patients

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