BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 15442810 · Received September 16, 2022

    Report

    Report Number
    2955842-2022-14036
    Event Type
    Malfunction
    Date Received
    September 16, 2022
    Date of Event
    August 17, 2022
    Report Date
    August 17, 2022
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110744
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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 CONFIRMED THE REPORTED ERROR AND REPLACED THE MASTER TOOL MANIPULATOR LEFT (MTML) TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI RECEIVED THE MTML UNIT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS INVESTIGATION WAS UNABLE TO REPRODUCE THE CUSTOMER REPORTED COMPLAINT, BUT COULD BE CONFIRMED AS HAVING OCCURRED VIA FIELD ERROR LOGS. A VISUAL INSPECTION WAS PERFORMED. THE ARM WAS INSTALLED ONTO THE SYSTEM AND POWERED UP. A SINE CYCLE AND A TEST DRIVE WERE PERFORMED WITHOUT ANY ISSUES. TESTS PERFORMED VIA MATLAB PASSED. THE FOLLOWING PARTS WILL BE REPLACED AS A PRECAUTION: EMBEDDED SERIALIZER FOR MASTER BASE (ESMB) PC EMBEDDED SERIALIZER IN MASTER PLATFORM (ESMP) PRINTED CIRCUIT ASSEMBLY (PCA) BLACK AND WHITE FFC'S, SLIP RING ASSY, SLIP RING BOARD, MAIN WIRE HARNESS, RJP PCA, RJS PCA, EMBEDDED SERIALIZER FOR MASTER YAW (ESMY) PCA, EMBEDDED SERIALIZER FOR MASTER HANDLE (ESMH) PCA, GIMBAL BLACK FFC, GIMBAL WHITE FFC, MJB PCA. THE MTM2 IS NO TROUBLE FOUND (NTF). SYSTEM LOG REVIEW WAS PERFORMED. PER THE REVIEW, THE FOLLOWING WAS CONFIRMED: AN APPENDECTOMY PROCEDURE WAS PERFORMED ON SYSTEM (B)(4) ON (B)(6) 2022. NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS SUBMITTED FOR REVIEW. THIS COMPLAINT IS BEING REPORTED BASED ON THE FOLLOWING CONCLUSION: THE CUSTOMER CONVERTED AFTER THE START OF THE PROCEDURE DUE TO THE MASTER TOOL MANIPULATOR LEFT LOCKING UP ON THE SURGEON SIDE CONSOLE. 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.

    Additional Manufacturer Narrative · 0

    FURTHER ENGINEERING INVESTIGATION ISSUE WAS FOUND TO HAVE ISSUES WITH RJS/RJP ONLY. THE RJS AND RJP WILL BE REPLACED AS A FIX.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED APPENDECTOMY SURGICAL PROCEDURE, SURGEON SIDE CONSOLE (SSC) LOCKED UP AND THE SURGEON HAD TO MOVE TO THE OTHER SSC TO CONTINUE WITH THE PROCEDURE. THE TECHNICAL SERVICE ENGINEER (TSE) VIEWED LOGS AND NOTED ERROR 25521 AND MASTER TOOL MANIPULATOR LEFT (MTML) BEING DISABLED ON THE SURGEON SIDE CONSOLE ONE (912030). THE SITE WAS COMPLETING THE PROCEDURE WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126830 DAVINCI XI SURGEON SIDE CONSOLE, SMART PEDALS NAY INTUITIVE SURGICAL, INC 380677-23 N/A 00886874110744

    Patients

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