BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 15520255 · Received September 30, 2022

    Report

    Report Number
    2955842-2022-14295
    Event Type
    Malfunction
    Date Received
    September 30, 2022
    Date of Event
    August 31, 2022
    Report Date
    August 31, 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
    MA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN ISI FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED COMPLAINT. THE FSE REPLACED THE MTM TO ADDRESS THE REPEATED FAULTS. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI RECEIVED THE UNIT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS (FA) INVESTIGATION WAS UNABLE TO REPLICATE THE ERROR 25510, BUT COULD CONFIRM IT VIA SYSTEM LOGS. VISUAL INSPECTION WAS PERFORMED. THE MTM WAS INSTALLED ONTO THE SYSTEM AND POWERED UP. 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: RJP PCA RJP MOUNT, RJS PCA AND RJS MOUNT, ESMY PCA, MJB PCA, GIMBAL WHITE FFC, GIMBAL BLACK FFC, ESMB PCA, ESMP PCA, BLACK AND WHITE FFC'S, SLIP RING ASSY, SLIP RING BOARD, MAIN WIRE HARNESS. THE MTM2 IS NTF. NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS SUBMITTED TO ISI FOR REVIEW. A REVIEW OF PROCEDURE LOG WAS PERFORMED. PER THE REVIEW, THE FOLLOWING WAS CONFIRMED: SYSTEM SERIAL # ((B)(4)), EVENT DATE ((B)(6) 2022),AND PROCEDURE (PROSTATECTOMY - SIMPLE). A REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE WAS CONDUCTED BY TSE. INVESTIGATION REVEALED THE FOLLOWING POSSIBLE RELATED SYSTEM ERRORS: ERROR 25521- LINK TO ESMH IS DOWN. ERROR 26005 - THE USER DISABLED MTMR. THIS COMPLAINT IS REPORTABLE DUE TO THE FOLLOWING: DURING A DUAL CONSOLE PROCEDURE, ONE SURGEON SIDE CONSOLE (SSC) BECAME UNAVAILABLE AFTER THE START OF A SURGICAL PROCEDURE (POST FIRST PORT INCISION) AND THE ISSUE COULD NOT BE RESOLVED. 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 PROSTATECTOMY - SIMPLE SURGICAL PROCEDURE, A RECOVERABLE FAULT WITH THE RIGHT MASTER TOOL MANIPULATOR (MTMR) WAS OBSERVED. AFTER RECOVERING FROM THE FAULT, THE SURGEON COULD NOT CONTROL CAMERA ON UNIVERSAL SURGICAL MANIPULATOR (USM) 2 AND 3; ONLY USM1 COULD BE CONTROLLED WITH THE MTML. THE TECHNICAL SUPPORT ENGINEER (TSE) REVIEWED THE SYSTEM LOGS AND OBSERVED ERROR 25521, FOLLOWED BY A ERROR 26005 SHOWING THE MTMR WAS DISABLED PRIOR TO RECOVERING FROM FAULT. TSE RECOMMENDED THE SURGEON MOVE TO CONSOLE 2 AND ATTEMPT CONTROLLING ALL THE USMS WITH BOTH MASTERS. SURGEON WAS ABLE TO CONTROL ALL ARMS WITH BOTH MASTERS. A FOLLOW-UP WITH A FIELD SERVICE ENGINEER (FSE) WAS REQUESTED. THE PROCEDURE COMPLETED AS PLANNED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND THE REPORTER WAS UNABLE TO PROVIDE ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2384636 DAVINCI XI SURGEON SIDE CONSOLE, SMART PEDALS NAY INTUITIVE SURGICAL, INC 380677-04 N/A 00886874110744

    Patients

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