BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 16169840 · Received January 14, 2023

    Report

    Report Number
    2955842-2022-16393
    Event Type
    Malfunction
    Date Received
    January 14, 2023
    Date of Event
    December 15, 2022
    Report Date
    December 15, 2022
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110744
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING ELECTRICAL DISCHARGE AT THE SURGEON SIDE CONSOLE (SSC) MONOPOLAR FOOT PEDAL, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. THE FSE WAS UNABLE TO REPRODUCE THE REPORTED ISSUE AND CONFIRMED THAT THE ISSUE HAD NOT RECURRED. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. THE COMPLAINT REGARDING THE ELECTRICAL DISCHARGE ISSUE WAS NOT CONFIRMED BASED ON THE FIELD EVALUATION. BASED ON THE INFORMATION AVAILABLE AT THIS TIME, THIS COMPLAINT IS BEING CLASSIFIED AS A REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION: IT WAS ALLEGED THAT THE SURGEON FELT AN ELECTRIC SHOCK AT THE SURGEON SIDE CONSOLE (SSC). WHILE THERE WAS NO HARM OR INJURY TO THE SURGEON OR THE PATIENT, THE REPORTED ISSUE COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF IT WERE TO RECUR.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED INGUINAL HERNIA SURGICAL PROCEDURE, THE SURGEON FELT ZAPPING AND BURNING ON THE SIDE OF HIS FOOT WHEN PRESSING ON THE RIGHT BLUE MONOPOLAR ENERGY PEDAL. THE CALLER INFORMED THAT THE ISSUE OCCURRED SEVEN TO EIGHT TIMES DURING THE PROCEDURE. THE TECHNICAL SUPPORT ENGINEER (TSE) VIEWED THE LOGS BUT DID NOT FIND ANY RELATED ERRORS. AT THE TIME OF THE CALL, THE ISSUE WAS NOT OCCURRING. THE TSE WALKED THE CALLER THROUGH POWER CYCLING THE SYSTEM. THE ISSUE DID NOT OCCUR AFTER POWER CYCLING. THE TSE ADVISED THE CALLER TO USE THE FOOT PEDALS IN THE VISION SIDE CART (VSC) DRAWER OR UTILIZE EXTERNAL ENERGY WITH THE EXTERNAL ENERGY CAUTERY PEDALS THAT COME WITH GENERATOR IF THE ISSUE RECURS. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED INJURY. ON 12/22/2022, THE FOLLOWING ADDITIONAL INFORMATION WAS OBTAINED: THE SURGEON PERFORMED THE PROCEDURE WITH SHOES ON. AFTER THE PROCEDURE, THE SURGEON TOOK OFF HIS SHOES AND WAS RUBBING HIS FOOT. THE NURSE DID NOT THINK THAT THE SURGEON WAS INJURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1564474 DAVINCI XI SURGEON SIDE CONSOLE, SMART PEDALS NAY INTUITIVE SURGICAL, INC 380677-06 N/A 00886874110744

    Patients

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