BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 16469713 · Received March 2, 2023

    Report

    Report Number
    2955842-2023-11020
    Event Type
    Malfunction
    Date Received
    March 2, 2023
    Date of Event
    January 4, 2023
    Report Date
    February 4, 2023
    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
    IN, US
    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 EVENT. FIELD SERVICE ENGINEER (FSE) CONFIRMED THE REPORTED ISSUE AND IDENTIFIED ERROR 23003 ON AXIS 5 OF THE UNIVERSAL SURGICAL MANIPULATOR (USM). THE USM WAS REPLACED TO RESOLVE THE ISSUE. ADDITIONALLY, THE FSE REPLACED THE MISSING CAP ON THE MANIPULATOR AND REPLACED A BROKEN ETHERNET JUMPER. THE THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI RECEIVED THE USM UNIT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. THE UNIT WAS TESTED ON AN IN-HOUSE SYSTEM AND PASSED NORMAL MODE. THE SYSTEM DID NOT TRIGGER ERRORS 23003 ON THE CARRIAGE DEGREES OF FREEDOM (DOF), BUT THEY WERE CONFIRMED VIA ERROR LOGS/SYSTEM LOGS. THE UNIT FAILED ON A PFTP AS IT FAILED THE CARRIAGE STRENGTH TEST ON DOF'S 5 AND 9. THE UNIT ALSO FAILED THE CARRIAGE FRICTION SPEED LOW TEST ON DOF 5 AND THE CARRIAGE FRICTION SPEED HIGH TEST ON DOF'S 5 AND 9. THE UNIT WAS TEST ON A PFTP AND PASSED DIRECTION TESTS, LISSAJOUS, CVA CHARACTERIZATION, SENSORS CHECK, SINE CYCLE, BRAKE RELEASE TEST, BRAKE HOLD TEST, ADVANCE BRAKE TEST, AND CARRIAGE SWITCHES TEST. THE TOP PLATE AND DOF'S 5 & 9 ROTORS AND GEARBOXES WILL BE REPLACED AS A FIX TO THE REPORTED PROBLEM. THE COMPLAINT WAS CONFIRMED BASED ON FAILURE ANALYSIS, WHICH INDICATES THAT THE DEVICE DID CONTRIBUTE TO THE CUSTOMER REPORTED ISSUE. IMAGE(S) AND/OR VIDEO CLIP(S) ASSOCIATED WITH THIS REPORTED EVENT WERE NOT SUBMITTED FOR REVIEW. THIS COMPLAINT IS BEING REPORTED BASED ON THE FOLLOWING CONCLUSION: WHILE THERE WAS NO HARM OR INJURY TO THE PATIENT, SYSTEM UNAVAILABILITY AFTER THE START OF A SURGICAL PROCEDURE COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF IT WERE TO RECUR AS IT 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 INGUINAL HERNIA SURGICAL PROCEDURE, THE SYSTEM WAS EXPERIENCING ERRORS AND NON-INTUITIVE MOTION. TECHNICAL SUPPORT ENGINEER (TSE) REVIEWED LOGS AND NOTED ARM 2 ERROR 23003 ON AXIS 4. CLINICAL SALES REPRESENTATIVE (CSR) IS GOING TO CHECK THE CAMERA TO SEE IF THE ROLL AXIS HAS FRICTION ON IT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER ON AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: SURGEONS HANDS WERE NOT DOING WHAT THEY WERE TELLING THEM TO DO. THE WAY IT WAS DESCRIBED TO THE CSR WAS FRICTION. THE DEVICE WAS NOT MOVING IN OPPOSITE DIRECTIONS. CONFIRMED THAT THE ENDOSCOPE THAT WAS USED IN THE PROCEDURE ON (B)(6)2023 WAS USED ON A CASE TODAY (B)(6)2023 AND THERE WAS NO ISSUE WITH NON-INTUITIVE MOTION. IT WAS USED ON THE SAME SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    504399 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-50 N/A 00886874110720

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Male DA VINCI INSTRUMENTS AND ACCESSORIES