BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 14666625 · Received June 11, 2022

    Report

    Report Number
    2955842-2022-12117
    Event Type
    Malfunction
    Date Received
    June 11, 2022
    Date of Event
    May 11, 2022
    Report Date
    May 11, 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
    PA, 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. FSE ARRIVED ON SITE AND COULD REPRODUCE THE DATA DROPS ON UNIVERSAL SURGICAL MANIPULATOR 4 (USM4). USM4 WAS REPLACED TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. THE USM INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED AND THE EVALUATION HAS BEEN COMPLETED. THE CUSTOMER-REPORTED ERRORS WERE CONFIRMED AND REPLICATED. TROUBLESHOOTING FOUND THAT THE PARALLELOGRAM FIBER CABLE WAS THE CAUSE OF THE ERRORS THAT WERE SEEN. THE ROOT CAUSE OF THE ISSUE WAS A COMPONENT FAILURE. NO IMAGE OR PROCEDURE VIDEO WAS PROVIDED FOR REVIEW. THIS COMPLAINT IS BEING REPORTED BASED ON THE FOLLOWING CONCLUSION: 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. FOLLOW-UP WAS ATTEMPTED, BUT THE MISSING PATIENT INFORMATION WAS EITHER UNKNOWN, UNAVAILABLE, NOT PROVIDED, OR NOT APPLICABLE. THE EXPIRATION DATE IS NOT APPLICABLE. THE PRODUCT IS NOT IMPLANTABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED UNILATERAL INGUINAL HERNIA SURGICAL PROCEDURE, THE CUSTOMER CALLED AN INTUITIVE SURGICAL INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) TO REPORT REPEATED RECOVERABLE FAULTS. SYSTEM LOGS CONFIRMED ERRORS REPORTED BY ARMNET4, INDICATING THAT THE LINK BETWEEN THE AXES CONTROLLER MOTOR (ACM) AND AXES CONTROLLER SPAR (ACS) WAS DOWN OR FAILING. THE ERROR RECURRED DURING THE TECHNICAL SUPPORT CALL AND THE CUSTOMER RECOVERED THE FAULT. CUSTOMER STATED THAT THEY COULD COMPLETE THE PROCEDURE AND THE NEXT PROCEDURE WITHOUT UNIVERSAL SURGICAL MANIPULATOR (USM4); HOWEVER, THEY WILL NEED ALL FOUR USMS FOR TOMORROW'S PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CUSTOMER REPORTED THAT THE PROCEDURE WAS COMPLETED WITH THREE ARMS; HOWEVER, THE SYSTEM WAS STILL FAULTING. ARM 4 WOULD FAULT WHEN NOT IN USE AND CAUSED DELAYS THROUGHOUT THE DAY. THERE WERE NO COLLISIONS OR EXTERNAL INTERFERENCE AND THEY WERE NOT ABLE TO USE THE ARM. INFORMATION REGARDING PATIENT DEMOGRAPHICS, RELEVANT TESTING, AND MEDICAL HISTORY WAS REQUESTED, HOWEVER THE REPORTER WAS NOT ABLE TO PROVIDE THAT INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1883448 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-38 N/A 00886874110720

    Patients

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