BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 15850699 · Received November 23, 2022

    Report

    Report Number
    2955842-2022-15464
    Event Type
    Malfunction
    Date Received
    November 23, 2022
    Date of Event
    October 24, 2022
    Report Date
    October 24, 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
    TX, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN ISI FIELD SERVICE ENGINEER (FSE) HAS BEEN DISPATCHED TO INVESTIGATE THE REPORTED EVENT. THE FSE REPLACED UNIVERSAL SURGICAL MANIPULATOR (USM) TO CORRECT THE 319-ERROR ASSOCIATED WITH ACC ON THE USM1. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS INVESTIGATIONS REPLICATED/CONFIRMED THE CUSTOMER REPORTED COMPLAINT. THE UNIT TESTED ON A IN HOUSE SYSTEM AND FAILED NORMAL MODE AS IT TRIGGERED 319 ERROR. REMOTE FE LOGGED ERRORS OF 319, 1126, 25730, 32114 & 40084. THE UNIT TESTED ON A PFTP AND FAILED FIBER TEST, POINTING TO ROLLING LOOP. DURING INSPECTION, ROLLING LOOP FIBER FOUND DAMAGED/TANGLED. THE ROLLING LOOP FIBER REPLACED WITH A GOLD ONE AND RETESTED ON A PFTP, THE UNIT PASSED ALL REQUIRED TESTS, EXCEPT PITCH FRICTION. FIBER ROLLING LOOP ASSEMBLY WILL REPLACE AS A FIX TO THE REPORTED PROBLEM. A PROCEDURE LOG REVIEW WAS PERFORMED. PER THE REVIEW, THE PULMONARY WEDGE RESECTION WAS PERFORMED ON (B)(6) 2022 VIA SYSTEM (B)(4). THIS COMPLAINT IS CONSIDERED A REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION: A UNIVERSAL SURGICAL MANIPULATOR (USM) WAS DISABLED AFTER THE START OF THE PROCEDURE AND THE SURGEON WAS ABLE TO CONTINUE WITH THE PROCEDURE ROBOTICALLY USING 3 ARMS. 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. SYSTEM UNAVAILABILITY AFTER START OF A SURGICAL PROCEDURE COULD LEAD TO THE PROCEDURE TO BE CONVERTED/ABORTED AND 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 SURGICAL PROCEDURE, THE CUSTOMER CALLED AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) AND REPORTED THAT THE SYSTEM WAS REPEATEDLY THROWING 319 FAULTS ON ARM1. THE TSE REVIEWED LOGS AND NOTED 319 ASSOCIATED WITH ACC ON UNIVERSAL SURGICAL MANIPULATOR 1 (USM1). TSE HAD CALL HARD CYCLE AND EPO SYSTEM WITH NO CHANGE ERROR CAME BACK. TSE NOTED THAT OPTIONS ARE TO CONTINUE AS A THREE-ARM SYSTEM OR SWAP OUT THE PATIENT SIDE CART (PSC). THE CALLER NOTED THAT THEY WILL PROCEED AS A 3-ARM SYSTEM. CALLER NOTED THAT ARM 1 WAS HOLDING ONTO TISSUE. ONCE ARM 1 WAS DISABLED SYSTEM COMPLETED BOOT UP AND TISSUE WAS RELEASED USING OTHER ARMS. THE CALLER STATED THAT INSTRUMENT AND CANNULA HAVE BEEN REMOVED FROM ARM 1. THE SITE POWER CYCLED THE SYSTEM 4-5 TIMES AND THE ERROR 319 WAS CONTINUING TO POPULATE. THE TSE EXPLAINED THE ARM 1 ERROR WOULD REQUIRE A FIELD SERVICE ENGINEER (FSE) SITE VISIT TO RESOLVE. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY. ISI FOLLOWED UP WITH THE CUSTOMER TO OBTAIN ADDITIONAL INFORMATION, BUT NO FURTHER DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    368221 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-40 N/A 00886874110720

    Patients

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