BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 15200154 · Received August 10, 2022

    Report

    Report Number
    2955842-2022-13391
    Event Type
    Malfunction
    Date Received
    August 10, 2022
    Date of Event
    July 12, 2022
    Report Date
    July 12, 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
    MA
    Reporter Occupation
    003

    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 CUSTOMER REPLACED THE UNIVERSAL SURGICAL MANIPULATOR (USM) TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI RECEIVED THE USM INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. THE UNIT WAS RETURNED FOR FAILURE ANALYSIS AND THE REPORTED FAILURE OF ERROR 23062 COULD NOT BE REPLICATED. THE UNIT WAS TESTED ON AN IN-HOUSE SYSTEM AND PASSED NORMAL MODE. HOWEVER, THE ERROR LOGS/SYSTEM LOGS SHOWED THAT THERE WERE VARIOUS 1164, 23062, AND 22020 ERRORS ON DEGREES OF FREEDOM (DOF) 7. THE UNIT WAS TESTED ON A PFTP AND PASSED DIRECTION TESTS, LISSAJOUS, CHIP-ENCODER VIRTUAL ABSOLUTE (CVA) CHARACTERIZATION, SENSORS CHECK, SINE CYCLE, FRICTION TEST, CARRIAGE FRICTION TEST, BRAKE RELEASE TEST, BRAKE HOLD TEST, ADVANCED BRAKE TEST, CARRIAGE STRENGTH TEST, AND CARRIAGE SWITCH TEST. THE ISA BOARD AND DOF 7 STATOR WILL BE REPLACED AND THE CARRIAGE WILL BE UPGRADED TO A -16 AS A PRECAUTION. NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS AVAILABLE FOR REVIEW. A REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE WAS CONDUCTED BY ISI TECHNICAL SUPPORT ENGINEER. INVESTIGATION REVEALED THE FOLLOWING POSSIBLE RELATED SYSTEM ERRORS: ERROR 23062 - A 3 PHASE MOTOR DID NOT RESPOND AS EXPECTED ON THE USM3, AXIS 6. A REVIEW OF THE PROCEDURE LOG WITH THE INFORMATION PROVIDED SHOWS SYSTEM SK2927 WAS USED ON (B)(6) 2022 FOR A PULMONARY LOBECTOMY SURGICAL PROCEDURE. THIS COMPLAINT IS CONSIDERED A REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION: A UNIVERSAL SURGICAL MANIPULATOR (USM) WAS ABANDONED 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 CONVERSION/ABORTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY LOBECTOMY SURGICAL PROCEDURE, THE INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR) WAS INFORMED THAT THE CUSTOMER EXPERIENCED REPEATED 23062 FAULTS POINTING TO UNIVERSAL SURGICAL MANIPULATOR (USM) 3 AXIS 6. THE SURGEON HAD ALREADY MOVED THE INSTRUMENT TO USM 4 AND PROCEEDED WITH THE PROCEDURE. THE ISI TECHNICAL SERVICE ENGINEER (TSE) ADVISED THAT AN EMERGENCY STOP AND A HARD POWER CYCLE WITH EMERGENCY POWER OFF COULD RESOLVE THE ISSUE. THE TSE STATED THAT THE ISSUE COULD LIKELY RETURN ONCE THOSE ACTIONS WERE TAKEN. THE SURGEON OPTED TO CONTINUE OPERATING. THE PROCEDURE WAS COMPLETING WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CUSTOMER INFORMED THAT SYSTEM FUNCTIONALITY WAS CHECKED UPON POWERING ON THE SYSTEM AND THE SYSTEM INITIALLY POWERED ON WITHOUT ERRORS. THE ISSUE OCCURRED UPON DOCKING AND LOADING THE INSTRUMENT ARMS. THE CUSTOMER CONFIRMED THAT USM 3 WAS DISABLED AND THEY MOVED THE INSTRUMENT TO USM4. USM3 WAS NOT USED FOR THE REMAINDER OF THE PROCEDURE. THE PROCEDURE WAS COMPLETED ROBOTICALLY WITH NO INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1606226 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