BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 13770281 · Received March 15, 2022

    Report

    Report Number
    2955842-2022-10617
    Event Type
    Malfunction
    Date Received
    March 15, 2022
    Date of Event
    February 9, 2022
    Report Date
    February 14, 2022
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110720
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED COMPLAINT. THE FSE WAS ABLE TO REPRODUCE THE REPORTED PROBLEM. ERRORS 307, 1007, AND 32100 OCCURRED WHEN THE FSE POWERED ON THE SYSTEM SEVERAL TIMES. THE FSE REVIEWED THE SYSTEM LOGS AND NOTED THAT ERROR 307 WAS INDICATING A CONFIGURED NODE ON THE PROXIMAL SET UP JOINT (PSUJ) STOPPED RESPONDING. ERROR 1007 WAS POINTING TO AN ERROR ON A POWER MONITOR DEVICE OF THE ALTERNATING CURRENT (AC) BOARD AND INITIAL NODE AC-1B (AXES CONTROLLER TORNADO [ACT] BOARD IN TORNADO). THE FSE ALSO NOTED THAT ERROR 32100 WAS POINTING TO A FAULTY AXES CONTROLLER SETUP (ACU) BOARD ON THE PSUJ. THE FSE REPLACED THE PSUJ TO RESOLVE THE REPORTED PROBLEM. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE PSUJ FOR EVALUATION, BUT EVALUATION HAS NOT BEEN COMPLETED AS OF THE DATE OF THIS REPORT. THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE HAS NOT BEEN DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED FOLLOWING COMPLETION OF THE EVALUATION. A REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE WAS CONDUCTED BY THE FSE. THE FSE IDENTIFIED ERRORS 307, 1007, AND 32100. IN ADDITION, A REVIEW OF THE SITE'S COMPLAINT HISTORY DOES NOT SHOW ANY ADDITIONAL COMPLAINTS RELATED TO THIS PRODUCT AND/OR THIS EVENT. NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS SUBMITTED TO ISI FOR REVIEW. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: SYSTEM UNAVAILABILITY AFTER START OF A SURGICAL PROCEDURE COULD LEAD TO THE PROCEDURE TO BE CONVERTED AND MAY LEAD TO AN INJURY DUE TO THE PATIENT¿S INABILITY TO TOLERATE A CONVERSION. WHILE THERE WAS NO HARM OR INJURY TO THE PATIENT, THE REPORTED FAILURE MODE COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF IT WERE TO RECUR.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION CAN BE FOUND IN THE FOLLOWING FIELDS: G3, G6, H2, AND H3. ANALYSIS INFORMATION CAN BE FOUND IN FIELDS H6 AND H10. D02 - INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE PROXIMAL SET UP JOINT (PSUJ) INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS INVESTIGATIONS COULD NOT REPRODUCE THE REPORTED ERROR. HOWEVER, THE ERROR WAS CONFIRMED VIA THE FIELD LOGS. THE UNIT WAS PLACED ON A PSC (PATIENT SIDE CART) FIXTURE TEST PLATFORM (PFTP) MACHINE, AND IT FAILED THE BRAKE TEST. A GOLDEN AXES CONTROLLER SETUP (ACU) WAS INSTALLED, AND IT PASSED ALL TESTS IN THE PFTP MACHINE. THE OLD ACU WAS REINSTALLED, AND THE SUJ FAILED THE BRAKE TEST AGAIN. THE FIBER OPTIC CABLE, HORIZONTAL HARNESS, AND ACU WOULD BE REPLACED AS A FIX. THE ROOT CAUSE OF THE REPORTED ISSUE WAS DETERMINED TO BE A COMPONENT FAILURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY LOBECTOMY SURGICAL PROCEDURE, THE CUSTOMER CALLED IN TO REPORT ERROR 307 OCCURRED ON UNIVERSAL SURGICAL MANIPULATOR (USM) 1. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. ON 14-FEB-2022, INTUITIVE SURGICAL, INC. (ISI) PERFORMED FOLLOW-UP AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: SYSTEM FUNCTIONALITY WAS NOT CHECKED PRIOR TO USE. ERROR 307 OCCURRED AFTER THE SYSTEM POWERED ON. THE CUSTOMER ELECTED TO DISABLE USM 1 AND CONTINUED WITH THE PROCEDURE WITH THE OTHER THREE USMS.

    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
    15853 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-48 N/A 00886874110720

    Patients

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