BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 16584185 · Received March 21, 2023

    Report

    Report Number
    2955842-2023-11430
    Event Type
    Malfunction
    Date Received
    March 21, 2023
    Date of Event
    February 21, 2023
    Report Date
    February 21, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110720
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING FAULTING, AN INVESTIGATION IS IN PROGRESS 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 WAS ABLE TO REPRODUCE THE CUSTOMER REPORTED ISSUE. THE FSE REPLACED THE PATIENT SIDE CART (PSC) BASE FIBER OPTIC CABLES, THE CABLE PORT DUE TO DAMAGE ON THE CONNECTOR AND INSTALLED NEW COVERS ON ALL THE OPERATING ROOM (OR) INTEGRATION PLATES. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. AN RMA WAS ISSUED TO EVALUATE THE INTUITIVE SURGICAL, INC. (ISI) DEVICE. ADDITIONAL INFORMATION IS BEING GATHERED TO DETERMINE THE CONTRIBUTION OF THE DEVICE TO THE CUSTOMER REPORTED ISSUE. THIS COMPLAINT IS REPORTABLE MALFUNCTION EVENT DUE TO THE FOLLOWING CONCLUSION: IT WAS ALLEGED THAT THE SYSTEM WAS FAULTING. THE FSE WAS ABLE TO REPRODUCE THE ISSUE AND REPLACED THE PARTS TO RESOLVE IT. 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 PROCEDURE CHANGE.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE FIBER OPTIC CABLE WAS ANALYZED AND THE REPORTED FAILURE WAS CONFIRMED. BASED ON VISUAL INSPECTION, THE CABLE WAS DAMAGED AT THE PORT/CONNECTOR. ROOT CAUSE IS ATTRIBUTED TO COMPONENT FAILURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED NEPHRECTOMY SURGICAL PROCEDURE, THE SYSTEM WAS FAULTING OUT. INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) REVIEWED THE SYSTEM LOGS AND FOUND 23 ERRORS FOR FIBER. THE CUSTOMER MOVED THE SYSTEM AROUND AND DID NOT THINK THAT THE SYSTEM WAS TURNED OFF BEFORE UNHOOKING THE BLUE FIBER CABLE. THE CUSTOMER HARD POWER CYCLED THE ENTIRE SYSTEM AND THE SYSTEM CAME UP WITH NO FIBER ERRORS, BUT CAME UP WITH ERRORS 17 AND 32 FOR THE LEFT MASTER TOOL MANIPULATOR (MTM). THE TSE HAD THE CUSTOMER HARD POWER CYCLE THE SURGEON'S CONSOLE AND RESTART IT AND THIS TIME THE SURGEON'S CONSOLE CAME UP GOOD AND SYSTEM WAS ERROR FREE. THE TSE DID NOTICE IN THE LOGS THAT 5 DAYS PRIOR THE LEFT MTM HAD THE SAME ERRORS. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

    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
    11655 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-35 N/A 00886874110720

    Patients

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