BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 16719264 · Received April 11, 2023

    Report

    Report Number
    2955842-2023-11897
    Event Type
    Malfunction
    Date Received
    April 11, 2023
    Date of Event
    March 20, 2023
    Report Date
    March 20, 2023
    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
    TX, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING IMAGE LOSS IN THE RIGHT EYE OF THE HIGH-RESOLUTION STEREO VIEWER (HRSV), AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. THE FIELD SERVICE ENGINEER VERIFIED THE CUSTOMER ISSUE, REPLACED THE HIGH-RESOLUTION STEREO VIEWER, AND PERFORMED CALIBRATION. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. INTUITIVE SURGICAL, INC DID RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS AND THE REPORTED FAILURE WAS REPLICATED FOR THE RIGHT EYE IN SURGEON SIDE CONSOLE (SSC). THE HIGH-RESOLUTION STEREO VIEWER WAS INSTALLED IN THE PRINTED CIRCUIT ASSEMBLY (PCA) TEST SYSTEM SURGEON SIDE CONSOLE AND THE UNIT POWERED UP WITHOUT VIDEO ON THE DISPLAY. THE COMPLAINT WAS CONFIRMED BASED ON FAILURE ANALYSIS, WHICH INDICATES THAT THE DEVICE DID CONTRIBUTE TO THE CUSTOMER REPORTED ISSUE. THE PROBABLE ROOT CAUSE IS ATTRIBUTED TO COMPONENT FAILURE. THIS COMPLAINT IS CONSIDERED A REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION: THE CUSTOMER WAS UNABLE TO SEE THE HIGH-RESOLUTION STEREO VIEWER (HRSV) RIGHT EYE AFTER THE START OF THE PROCEDURE DUE TO A LOSS OF IMAGE. 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 GASTRIC BYPASS SURGICAL PROCEDURE, THE CUSTOMER LOST VIDEO IN THE RIGHT EYE OF THE HIGH-RESOLUTION STEREO VIEWER (HRSV). THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1862904 DAVINCI XI SURGEON SIDE CONSOLE, SMART PEDALS NAY INTUITIVE SURGICAL, INC 380677-13 N/A 00886874110744

    Patients

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