BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 16402594 · Received February 20, 2023

    Report

    Report Number
    2955842-2023-10747
    Event Type
    Malfunction
    Date Received
    February 20, 2023
    Date of Event
    January 25, 2023
    Report Date
    January 25, 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
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING RIGHT EYE VISION LOSS IN THE SSC, 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 POWERED ON THE SYSTEM AND WAS ABLE TO DUPLICATE THE CUSTOMER REPORTED PROBLEM. THE FSE VERIFIED THE RIGHT EYE OUTPUT OF PMSC. THE FSE REMOVED THE SSC HIGH RESOLUTION STEREO VIEWER (HRSV) COVER AND GAINED ACCESS TO THE RIGHT MONITOR DVI CONNECTION. THE FSE REMOVED THE DVI CABLE FROM THE MONITOR AND INSTALLED AN EXTERNAL CABLE CONNECTED TO THE VISION SIDE CART (VSC) OUTPUT AND VERIFIED THE IMAGE FROM THE VSC WAS DISPLAYED IN THE MONITOR. THE FSE RE-INSTALLED THE ORIGINAL MONITOR DVI CABLE AND VERIFIED THE IMAGE WAS PRESENT. THE FSE MANIPULATED THE DVI CABLE, PERFORMED SEVERAL POWER CYCLES, AND VERIFIED THE IMAGE WAS PROPERLY DISPLAYED IN THE HRSV. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. THE COMPLAINT REGARDING RIGHT EYE VISION LOSS IN THE SSC WAS CONFIRMED BASED ON THE FIELD EVALUATION, WHICH INDICATES THAT THE DEVICE DID CONTRIBUTE TO THE CUSTOMER REPORTED ISSUE. BASED ON THE INFORMATION AVAILABLE AT THIS TIME, THIS COMPLAINT IS BEING CLASSIFIED AS A REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION: THE CUSTOMER LOST VISION IN THE RIGHT EYE OF THE SURGEON SIDE CONSOLE (SSC) WITH NO RESOLVE. 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 ETEP SURGICAL PROCEDURE, THE CUSTOMER LOST VISION IN THE RIGHT EYE OF THE SURGEON SIDE CONSOLE (SSC). THE TECHNICAL SUPPORT ENGINEER (TSE) VIEWED THE LOGS BUT DID NOT SEE ANY RELATED ERRORS IN THE LOGS. THE TSE RECOMMENDED RESEATING THE SCOPE CABLE, TRYING A NEW SCOPE AND REBOOTING THE SYSTEM, BUT THE ISSUE REMAINED. THE CALLER INFORMED WHEN THEY UNPLUGGED THE SCOPE, THEY HAD COLOR BARS IN THE LEFT EYE, BUT THE RIGHT EYE WAS STILL BLACK. THE TSE HAD THE CUSTOMER PLUG THE SCOPE BACK IN AND VIEW THE RIGHT AND LEFT EYE ON THE VISION SIDE CART (VSC) TOUCHSCREEN AND BOTH THE RIGHT AND LEFT EYE WERE WORKING ON THE VSC MONITOR. THE PROCEDURE WAS COMPLETED AS PLANNED 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1407935 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-31 N/A 00886874110898

    Patients

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