BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 15514381 · Received September 30, 2022

    Report

    Report Number
    2955842-2022-14273
    Event Type
    Malfunction
    Date Received
    September 30, 2022
    Date of Event
    August 30, 2022
    Report Date
    August 30, 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

    AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED COMPLAINT. THE FSE WAS UNABLE TO REPRODUCE THE REPORTED PROBLEM. THE FSE REVIEWED THE SYSTEM LOG AND NOTED THAT ERROR 26002 HAD OCCURRED ON THE 25TH. THE CUSTOMER INFORMED THE FSE THAT UNIVERSAL SURGICAL MANIPULATOR (USM) 3 WOULD NOT MOVE AND WAS RESOLVED WITH A POWER CYCLE. THE ISSUE OCCURRED TWICE DURING THE PROCEDURE. THE FSE NOTED THAT THE ERROR LOG WAS POINTING TO AN ISSUE WITH USM 3. THE FSE REPLACED USM 3 TO RESOLVE THE REPORTED PROBLEM. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI RECEIVED THE USM INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS INVESTIGATIONS WAS UNABLE TO REPRODUCE THE REPORTED PROBLEM. THE UNIT WAS TESTED ON AN IN HOUSE SYSTEM AND PASSED NORMAL MODE. HOWEVER, THE ERROR LOGS/SYSTEM LOGS SHOWED THAT THERE WERE VARIOUS 307, 319, AND 26002 ERRORS. THERE WAS A COMPLETE INSPECTION ON THE UNIT AND NO PROBLEMS COULD BE FOUND. THE UNIT WENT THROUGH TESTING ON A PSC FIXTURE TEST PLATFORM AND PASSED DIRECTION TESTS, LISSAJOUS, CHIP ENCODER VIRTUAL ABSOLUTE CHARACTERIZATION, SENSORS CHECK, SINE CYCLE, FRICTION TEST, CARRIAGE FRICTION TEST, BRAKE RELEASE TEST, BRAKE HOLD TEST, ADVANCED BRAKE TEST, CARRIAGE STRENGTH TEST, AND CARRIAGE SWITCHES TEST. THE FCP BOARD & HARNESS WILL BE REPLACED AS A PRECAUTION FOR THE REPORTED PROBLEM. A PROCEDURE LOG REVIEW WAS PERFORMED. PER THE REVIEW, THE FOLLOWING WAS CONFIRMED: A TRANSORAL THYROIDECTOMY PROCEDURE WAS PERFORMED ON SYSTEM SK4083 ON (B)(6) 2022. 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: A USM WAS ABANDONED AFTER THE START OF THE PROCEDURE AND THE SURGEON WAS ABLE TO CONTINUE WITH THE PROCEDURE ROBOTICALLY USING THE OTHER ARMS. SYSTEM UNAVAILABILITY AFTER THE 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. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED TRANSORAL THYROIDECTOMY SURGICAL PROCEDURE, THE CUSTOMER CALLED IN TO REPORT THAT ERROR 26002 OCCURRED, AND AN INSTRUMENT ON UNIVERSAL SURGICAL MANIPULATOR (USM) 3 WOULD NOT MOVE. THE CUSTOMER REBOOTED THE SYSTEM, AND NORMAL SYSTEM OPERATION WAS RESTORED. SYSTEM FUNCTIONALITY WAS REPORTEDLY CHECKED PRIOR TO USE, AND NO ISSUES/ERRORS WERE NOTED. THE CUSTOMER ALSO REPORTED THAT THE SAME ERROR/ISSUE HAD OCCURRED PREVIOUSLY. THE SITE CONTINUED WITH THE PROCEDURE AS PLANNED. THERE WAS NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) PERFORMED FOLLOW-UP AND OBTAINED THE FOLLOWING ADDITIONAL/UPDATED INFORMATION REGARDING THE REPORTED EVENT: AFTER THE SYSTEM REBOOT, THE SITE CONTINUED AND COMPLETED THE PROCEDURE SUCCESSFULLY WITHOUT USM 3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1538850 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-49 N/A 00886874110720

    Patients

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