BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 16856175 · Received May 2, 2023

    Report

    Report Number
    2955842-2023-12332
    Event Type
    Malfunction
    Date Received
    May 2, 2023
    Date of Event
    March 16, 2023
    Report Date
    April 6, 2023
    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
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THE RIGHT YELLOW PEDAL WORKING INTERMITTENTLY, 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 REPLICATE THE REPORTED ISSUE; HOWEVER REPLACED THE FOOTREST TO RESOLVE THE REPORTED ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. THE FOOTREST WAS ANALYZED AND FAILURE ANALYSIS INVESTIGATION WAS ABLE TO REPLICATE/CONFIRM THE CUSTOMER REPORTED ISSUE. FAILURE ANALYSIS INSTALLED FOOTREST INTO PCA XI SYSTEM AND FOUND THE RIGHT YELLOW PEDAL IS NOT FUNCTIONAL PROPERLY WHEN PRESSED. THIS COMPLAINT IS REPORTABLE MALFUNCTION EVENT DUE TO THE FOLLOWING CONCLUSION: THE CUSTOMER ABORTED TO ANOTHER SYSTEM AFTER THE START OF THE PROCEDURE DUE TO INTERMITTENT FOOT PEDAL ISSUES. THE FSE REPLACED THE FOOTREST TO RESOLVE THE REPORTED ISSUE. FAILURE ANALYSIS WAS ABLE TO REPLICATE THE CUSTOMER REPORTED ISSUE. WHILE THERE WAS NO HARM OR INJURY TO THE PATIENT, SYSTEM UNAVAILABILITY AFTER THE START OF A SURGICAL PROCEDURE COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF IT WERE TO RECUR AS IT MAY LEAD TO AN INJURY DUE TO THE PATIENT¿S INABILITY TO TOLERATE A PROCEDURE CHANGE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LIVER RESECTION SURGICAL PROCEDURE, THE RIGHT YELLOW PEDAL WAS WORKING INTERMITTENTLY ON THE SURGEON SIDE CONSOLE (SSC) 1. INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) REVIEWED THE SYSTEM LOGS AND FOUND NO ERRORS. PRIOR TO CALLING, THE SURGEON SWITCHED TO THE SURGEON SIDE CONSOLE (SSC) 2. THE TSE SUGGESTED TO USE COMPRESSED AIR TO BLOW UNDER THE PEDAL TO POSSIBLY CLEAN OUT DUST AND DEBRIS FROM UNDER THE PEDAL. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER ON AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE PROCEDURE WAS COMPLETED ROBOTICALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1533557 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