BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 18793111 · Received February 27, 2024

    Report

    Report Number
    2955842-2024-11725
    Event Type
    Malfunction
    Date Received
    February 27, 2024
    Date of Event
    February 1, 2024
    Report Date
    February 1, 2024
    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
    SZ
    Reporter Occupation
    003

    Narratives

    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 WAS UNABLE TO REPRODUCE THE ISSUE BUT REPLACED THE HEAD SENSOR AND THE TOUCHSCREEN. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. AN RMA WAS ISSUED TO EVALUATE THE INTUITIVE SURGICAL, INC. (ISI) DEVICE. ADDITIONAL INFORMATION IS BEING GATHERED TO DETERMINE THE CONTRIBUTION OF THE DEVICE TO THE CUSTOMER REPORTED ISSUE.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE TOUCH SCREEN A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE TOUCH SCREEN WAS EVALUATED BY THE FAILURE ANALYSIS (FA) TEAM. FA WAS NOT ABLE TO REPRODUCE THE REPORTED COMPLAINT. THE UNIT WAS INSTALLED ONTO THE TEST SYSTEM AND UPON STARTUP IT BEHAVED NORMALLY. IT RESPONDED TO ALL FUNCTIONAL TESTING; CALIBRATION TEST PASSED WELL. THE SYSTEM WAS SET TO RUN THROUGH 10 POWER CYCLES AND LEFT IDLE FOR 20 MINUTES AND WAS MONITORED AND TESTED INTERMITTENTLY THROUGHOUT. THE UNIT DID NOT PROVIDE ANY ABNORMAL BEHAVIOR. UPON VISUAL INSPECTION, THE UNIT WAS IN GOOD CONDITION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CLINICAL SALES REPRESENTATIVE (CSR) CALLED IN TO REPORT THAT THE SURGEON ENCOUNTERED ERROR MESSAGES STATING "FOLLOW ON MATCHING GRIP REQUEST" MULTIPLE TIMES. THE CALLER STATED THAT THIS OCCURRED BETWEEN 20 TO 30 TIMES DURING YESTERDAY'S SURGERY. THE CALLER STATED THAT IT'S AN EXPERIENCED SURGEON (LESS LIKELY USER INDUCED ERROR). THE CALLER NOTICED THAT THE ISSUE OCCURRED ONLY ON ONE SURGEON SIDE CONSOLE (SSC). DUE TO THAT, THEY ASKED THE SURGEON TO MOVE TO THE OTHER CONSOLE AND NO ERROR AFTERWARDS. THE TECHNICAL SUPPORT ENGINEER (TSE) FOUND NOTHING RELEVANT IN THE LOGS. A POTENTIAL ISSUE RELATED ONLY TO THE SSC WITH THE BEHAVIOR DESCRIBED IS A TOUCHPAD ISSUE IN SENSITIVITY. THE TSE ASKED THE CALLER TO REMIND THE USER TO CALL TSE DIRECTLY NEXT TIME AND THE CALLER WILL DO SO. ACTUAL ONGOING SURGERY ON THE OTHER SSC WAS WORKING WITHOUT ISSUE. THE USER DIDN'T TRY TO USE THE SUSPECTED SSC THE NEXT DAY. THE PROCEDURE WAS CONVERTED TO ANOTHER SSC WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) MADE MULTIPLE ATTEMPTS AND OBTAINED ADDITIONAL INFORMATION. THE SYSTEM FUNCTIONALITY WAS CHECKED UPON POWERING ON THE SYSTEM. THE SYSTEM INITIALLY POWERS ON WITHOUT ERRORS. THE PROCEDURE WAS NOT INTENDED TO BE A DUAL CONSOLE PROCEDURE. THE ISSUE HAS OCCURRED FOR SEVERAL SURGERIES.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1629570 DAVINCI XI SURGEON SIDE CONSOLE, SMART PEDALS NAY INTUITIVE SURGICAL, INC 380677-06 N/A 00886874110744

    Patients

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