BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 17728249 · Received September 12, 2023

    Report

    Report Number
    2955842-2023-18389
    Event Type
    Injury
    Date Received
    September 12, 2023
    Date of Event
    August 16, 2023
    Report Date
    August 16, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110744
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CURRENT INFORMATION PROVIDED, THE SURGEON CONVERTED THE PROCEDURE TO OPEN SURGERY DUE TO REPEATED 23025 ERRORS. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. THE FSE WAS ABLE TO REPRODUCE THE ISSUE AND REPLACED THE RIGHT MASTER TOOL MANIPULATOR (MTM). THE SYSTEM WAS TESTED AND WAS READY FOR USE. ISI DID RECEIVE THE MTM TO PERFORM FAILURE ANALYSIS. THE REPORTED FAILURE (ERROR 23025 ALONG AXIS 3) WAS ABLE TO BE REPRODUCED DURING SINE CYCLE. THE COMPLAINT REGARDING THE 23025 ERROR WAS CONFIRMED BY FAILURE ANALYSIS, WHICH INDICATES THAT THE DEVICE MAY HAVE CONTRIBUTED TO THE CUSTOMER REPORTED ISSUE. AN ISI TECHNICAL SUPPORT ENGINEER REVIEWED THE SYSTEM LOGS AND FOUND AN ENCODER QUADRATURE FAULT AGAINST THE RIGHT MASTER TOOL MANIPULATOR.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED BILATERAL INGUINAL HERNIA SURGICAL PROCEDURE THAT A REPEATED 23025 ERROR OCCURRED AGAINST THE RIGHT MASTER TOOL MANIPULATOR (MTM). PRIOR TO CALLING THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE), THE CUSTOMER CONVERTED TO AN OPEN PROCEDURE AFTER NUMEROUS ATTEMPTS TO POWER CYCLE THE SYSTEM. AFTER EACH POWER CYCLE, THE MTM WOULD FAULT WITH ERROR 23025. THE CALLER WAS UNABLE TO RECOVER THE ERROR. INTUITIVE SURGICAL, INC. (ISI) ATTEMPTED FOLLOW-UP TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAD BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642817 DAVINCI XI SURGEON SIDE CONSOLE, SMART PEDALS NAY INTUITIVE SURGICAL, INC 380677-17 N/A 00886874110744

    Patients

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