BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 15643041 · Received October 20, 2022

    Report

    Report Number
    2955842-2022-14721
    Event Type
    Malfunction
    Date Received
    October 20, 2022
    Date of Event
    September 20, 2022
    Report Date
    September 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
    MS, 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 FSE VERIFIED THE ERRORS ON UNIVERSAL SURGICAL MANIPULATOR (USM) 2 AND REPLACED THE USM TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI RECEIVED THE PART(S) INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. THE UNIT WAS RETURNED FOR FAILURE ANALYSIS AND THE REPORTED FAILURES OF ERRORS 319, 25730, AND 32097, WERE CONFIRMED AND REPLICATED. THE UNIT WAS TESTED ON AN IN HOUSE SYSTEM AND FAILED NORMAL MODE AS IT TRIGGERED 25730 AND 32097 ERRORS ON THE ROLLING LOOP. DURING THE INSPECTION, IT WAS NOTED THAT THE ROLLING LOOP WAS DAMAGED AND COMING OFF ITS TRACK AND TRIGGERING ERROR 25730 AND 32097. THE UNIT FAILED ON A PFTP AS IT FAILED THE FIBER TEST ON THE ROLLING LOOP. THE UNIT WAS TESTED ON A PFTP AND PASSED DIRECTION TEST, LISSAJOUS, CVA CHARACTERIZATION, SINE CYCLE, FRICTION TEST, CARRIAGE FRICTION TEST, BRAKE RELEASE TEST, BRAKE HOLD TEST, ADVANCED BRAKE TEST, CARRIAGE STRENGTH TEST, AND CARRIAGE SWITCHES TEST. THE ROLLING LOOP ASSEMBLY WILL BE REPLACED AS A FIX TO THE REPORTED PROBLEM. A REVIEW OF THE PROCEDURE LOG SHOWED A HYSTERECTOMY ¿ BENIGN PROCEDURE WAS PERFORMED ON (B)(6) 2022 ON SYSTEM (B)(4). A REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE WAS CONDUCTED BY THE TSE. INVESTIGATION REVEALED THE FOLLOWING POSSIBLE RELATED SYSTEM ERRORS: ERROR 32097 - MOTOR AXIS (MAXIS) ERROR OCCURRED, REPORTED BY AXES CONTROLLER MOTOR (ACM) IN USM2 ERROR 307 - NODE NOT PRESENT: AXES CONTROLLER CANNULA (ACC) IN ARMNET2 USM. A NODE CONFIGURED TO BE PRESENT HAS STOPPED RESPONDING. (THE NODE WAS PRESENT AT STARTUP) ERROR 40084 - A COMM LINK FROM THE AXES CONTROLLER SPAR (ACS) IN ARM2 USM IS DOWN. THIS COMPLAINT IS CONSIDERED A REPORTABLE EVENT DUE TO 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. THE USM REQUIRED REPLACEMENT. 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 CONVERSION/ABORTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED BENIGN HYSTERECTOMY - BENIGN SURGICAL PROCEDURE, THE CUSTOMER EXPERIENCED ERROR 319 ON UNIVERSAL SURGICAL MANIPULATOR (USM) 2. THE TECHNICAL SUPPORT ENGINEER (TSE) VERIFIED ERRORS 307, 319 AND 32097 POINTING TO THE COMMUNICATION IN USM2. PRIOR TO CALLING, THE CUSTOMER TRIED A SYSTEM POWER CYCLE WITH NO SUCCESS. THE TSE EXPLAINED TO THE CUSTOMER THAT THEY WOULD NEED TO DISABLE USM2 TO CONTINUE WITH THIS SYSTEM. THE SURGEON DECIDED TO CONTINUE WITH USING USM1 IN PLACE OF USM2 AND THE TSE WALKED THEM THROUGH DISABLING USM2. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) IS PERFORMING FOLLOW-UP 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
    361255 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-43 N/A 00886874110720

    Patients

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