BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 16375979 · Received February 14, 2023

    Report

    Report Number
    2955842-2023-10683
    Event Type
    Malfunction
    Date Received
    February 14, 2023
    Date of Event
    January 25, 2023
    Report Date
    January 25, 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
    JA
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING NON-RECOVERABLE ERROR 23025, 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 INSPECTED THE SYSTEM AND CONFIRMED THE FAILURE OCCURRED ON THE MASTER TOOL MANIPULATOR RIGHT (MTMR). THE FSE REPLACED THE MTMR. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI DID RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE MTMR WAS ANALYZED AND FAILED DURING SINE CYCLE FOR ERROR 23025 WITH THE ORIGINAL AXIS 1 MOTOR INSTALLED. A GOLDEN MOTOR WAS INSTALLED ON AXIS 1 AND ALL TESTS PERFORMED WERE PASSED. THE AXIS 1 MOTOR AND MOTOR CABLE WILL BE REPLACED AS A FIX. THE COMPLAINT REGARDING ERROR 23025 WAS CONFIRMED BASED ON THE FIELD EVALUATION AND FAILURE ANALYSIS, WHICH INDICATES THAT THE DEVICE DID CONTRIBUTE TO THE CUSTOMER REPORTED ISSUE. THIS COMPLAINT IS BEING CLASSIFIED AS A REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION: THE CUSTOMER CONVERTED AFTER THE START OF THE PROCEDURE DUE TO NON-RECOVERABLE FAULT 23025 POINTED TO MTMR 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 CONVERSION/ABORTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED GASTRECTOMY SURGICAL PROCEDURE, NON-RECOVERABLE ERROR 23025 OCCURRED POINTED TO MASTER TOOL MANIPULATOR RIGHT (MTMR) AXIS 1. THE CUSTOMER PERFORMED A HARD POWER CYCLE OF THE SYSTEM, BUT THE ERROR WAS NOT RESOLVED. THE PROCEDURE WAS CONVERTED TO LAPAROSCOPIC SURGERY WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH A MEDICAL ENGINEER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE ISSUE WAS IDENTIFIED DURING PROCEDURE WITH PORTS ALREADY PLACED. SYSTEM FUNCTIONALITY WAS CHECKED UPON POWERING ON THE SYSTEM AND NO ERRORS OCCURRED AT THE TIME. THE CUSTOMER HAD CONTACTED FOR TECHNICAL SUPPORT AND TROUBLESHOOTING WAS COMPLETED; HOWEVER, THE SURGEON WAS UNABLE TO MANIPULATE THE ARMS DUE TO MTM FAILURE AND THE PROCEDURE WAS CONVERTED LAPAROSCOPICALLY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO INCREASED PORT INCISION OR ADDITIONAL PORTS. THERE WAS NO INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166505 DAVINCI XI SURGEON SIDE CONSOLE, SMART PEDALS NAY INTUITIVE SURGICAL, INC 380677-24 N/A 00886874110744

    Patients

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