BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 13859264 · Received March 23, 2022

    Report

    Report Number
    2955842-2022-10710
    Event Type
    Malfunction
    Date Received
    March 23, 2022
    Date of Event
    February 20, 2022
    Report Date
    February 20, 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
    AZ, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    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 COMPLAINT. THE ISI FSE FOUND AN ERROR 319 ON THE SYSTEM. THE ISI FSE REPLACED THE UNIVERSAL SURGICAL MANIPULATOR 1 (USM) AND THE ERROR WAS RESOLVED. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI RECEIVED THE USM PART INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS INVESTIGATION CONFIRMED AND REPLICATED THE CUSTOMER REPORTED COMPLAINT OF ¿REPEATED ERRORS 319¿. THE UNIT FAILED THE NORMAL MODE ON THE SYSTEM AND TRIGGERED 319 ERROR POINTING TO CLOCK SPRING FIBER CABLE. ALL THE CONNECTIONS WERE VISUALLY INSPECTED AND NO ISSUES WERE FOUND. THE TECHNICIAN PLACED A TEST FIBER CABLE FROM AXES CONTROLLER ARM (ACA) PRINTED CIRCUIT ASSEMBLY (PCA) TO AXES CONTROLLER MOTOR (ACM) PCA AND FIXED THE ISSUE. THEN, THE TECHNICIAN RE-CONNECTED THE ORIGINAL CLOCK SPRING FIBER CABLE AND 319 ERROR OCCURRED AGAIN. THE UNIT WAS ALSO TESTED ON PFTP WITH THE TEST FIBER CABLE AND PASSED DIRECTION TEST, CARRIAGE LISSAJOUS, FRICTION TESTS, CARRIAGE STRENGTH, LED TESTS, FIBER TEST, FAN TESTS, SINE CYCLE BRAKE TESTS, AND CARRIAGE SWITCHES. AS A FIX, THE CLOCK SPRING HARNESS ASSEMBLY AND AXES CONTROLLER SPAR CONNECTOR (ACSC) PCA WILL BE REPLACED TO ADDRESS THE REPORTED PROBLEM. A REVIEW OF THE SITE'S COMPLAINT HISTORY DOES NOT SHOW ANY ADDITIONAL COMPLAINTS RELATED TO THIS PRODUCT. NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS SUBMITTED FOR REVIEW. A REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE WAS CONDUCTED BY ISI TECHNICAL SUPPORT WHEN THE CUSTOMER CALLED FOR SUPPORT. INVESTIGATION REVEALED MULTIPLE ERRORS OCCURRED DURING THE SURGICAL PROCEDURE THAT WERE RELATED TO THE REPORTED COMPLAINT. THIS COMPLAINT IS REPORTABLE DUE TO THE FOLLOWING: A 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 COLORECTAL SURGICAL PROCEDURE, AN ERROR 319 ON THE UNIVERSAL SURGICAL MANIPULATOR 1 (USM) WAS DISPLAYED. LOGS REFLECTED ERROR 319 POINTING TO AXES CONTROLLER MOTOR (ACM), AXES CONTROLLER SPAR (ACS), AND AXES CONTROLLER CARRIAGE POWER (ACCP) NODES IN USM1. PRIOR TO CALLING TECHNICAL SUPPORT, THE STAFF ATTEMPTED TWO POWER CYCLES WITH NO CHANGE. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) WALKED THE STAFF THROUGH A 3RD POWER CYCLE WITH THE BREAKER AND EMERGENCY POWER OFF (EPO) WITH NO CHANGE. THE ISI TSE EXPLAINED THE USM WOULD REQUIRE AN ISI FIELD SERVICE ENGINEER (FSE) VISIT TO RESOLVE. THE STAFF ELECTED TO DISABLE USM1 AND PROCEED WITH THREE ARMS FOR THE PROCEDURE. THE SITE WAS CONTINUING THE PROCEDURE WITH NO REPORTED INJURY. ISI MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    549782 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-46 N/A 00886874110720

    Patients

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