BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 17865830 · Received October 3, 2023

    Report

    Report Number
    2955842-2023-18950
    Event Type
    Malfunction
    Date Received
    October 3, 2023
    Date of Event
    September 6, 2023
    Report Date
    September 6, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110898
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 FSE COULD NOT REPRODUCE THE REPORTED ISSUE BUT REPLACED THE ENDOSCOPIC CONTROLLER (EC). THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI DID RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM THE FAILURE ANALYSIS. THE ENDOSCOPIC CONTROLLER (EC) WAS INSTALLED INTO THE TEST SYSTEM AND FAILED WITH AN ERROR 48204 DURING THE VIDEO TEST. THE IMAGE TURNED YELLOW AT THE VISION SIDE CART (VSC) MONITOR. IT WAS NOTED THAT THE LIGHT ENGINE CAUSED THE ISSUE AND WOULD BE REPLACED. THE LIGHT ENGINE AND ENDOSCOPIC CONTROLLER POWER DISTRIBUTION (ECPD) WOULD BE REPLACED. THE COMPLAINT WAS CONFIRMED BASED ON THE FAILURE ANALYSIS, WHICH INDICATES THAT THE DEVICE MAY HAVE CONTRIBUTED TO THE CUSTOMER REPORTED ISSUE. AN INTUITIVE SURGICAL, INC. (ISI) SENIOR FAILURE ANALYSIS ENGINEER (FAE) PERFORMED A REVIEW OF THE ADVANCED TECHNICAL REVIEW ASSOCIATED WITH THIS EVENT. THE FOLLOWING ADDITIONAL INFORMATION WAS PROVIDED: THE ERROR OBSERVED BY THE CUSTOMER WOULD HAVE ALSO AFFECTED THE SURGEON SIDE CONSOLE (SSC). THE ERROR COULD HAVE ALSO CAUSED THE SSC TO EXPERIENCE THE YELLOW IMAGE. A REVIEW OF THE ADVANCED TECHNICAL REVIEW ASSOCIATED WITH THIS EVENT HAS BEEN PERFORMED BY AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT MANAGER. THE FOLLOWING ADDITIONAL INFORMATION WAS PROVIDED: THE TECHNICAL SUPPORT CAPTURED THE ISSUE ¿EXACTLY¿ HOW THE CUSTOMER VERBALLY REPORTED IT. THE CUSTOMER WAS REFERRING TO THE IMAGE APPEARING GRAY AND MISCOLORED, AND THAT CUSTOMER HAD A PREVENTATIVE MAINTENANCE MESSAGE (PMA) APPEAR ON THE SCREEN (THE PMA IS CAPTURED IN THE LOGS AS AN ERROR 48204). THE MISCOLORED IMAGE AND THE PMA MESSAGE ARE RELATED. THE TECHNICAL REVIEW CONFIRMED THE ISSUE HAPPENED DURING THE PROCEDURE AND WAS COMPLETED WITH NO DELAYS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED INGUINAL HERNIA SURGICAL PROCEDURE, THE SYSTEM SHOWED THE IMAGE WAS GOING TO BE MISCOLORED. AN INTUITIVE SURGICAL INC (ISI) TECHNICAL SUPPORT ENGINEER (TSE) REVIEWED THE SYSTEM LOGS AND FOUND AN ERROR 48204. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL INC (ISI) FOLLOWED UP WITH THE FIELD SERVICE ENGINEER (FSE) AND RECEIVED THE FOLLOWING ADDITIONAL INFORMATION: THE FSE DID NOT FIND ANY MISCOLORED IMAGE ON THE VISION SIDE CART (VSC) MONITOR. BUT THE FSE NOTED THE ERROR AND REPLACED THE ENDOSCOPIC CONTROLLER (EC).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    117804 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-19 N/A 00886874110898

    Patients

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