BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 14403943 · Received May 15, 2022

    Report

    Report Number
    2955842-2022-11648
    Event Type
    Malfunction
    Date Received
    May 15, 2022
    Date of Event
    April 15, 2022
    Report Date
    April 15, 2022
    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
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED COMPLAINT. THE REPORTED COMPLAINT WAS NOT CONFIRMED BASED ON THE FIELD EVALUATION. THE SYSTEM POWERED ON AND FUNCTIONED PROPERLY AND ERROR FREE. THE FSE REMOVED THE PATIENT SIDE CART (PSC) BASE COVERS AND NOTED NO UNUSUAL ODORS. THE FSE PERFORMED A VISUAL INSPECTION OF THE SYSTEM AND FOUND NO SIGNS OF OVERHEATING OR SMOKE. THE FSE CLEANED THE VISION SIDE CART (VSC) AND PSC FILTERS. THE FSE DID NOT FIND ANY SYSTEM BASED SOURCE OF THE ODOR DESCRIBED BY THE STAFF. THE FSE PERFORMED AN ELECTRICAL SAFETY TEST AND ALL READINGS PASSED. THE SYSTEM WAS TESTED AND VERIFIED READY FOR USE. THE EVENT WAS VERIFIED BY THE INTUITIVE TECH SUPPORT ENGINEER. PER THE REVIEW, THE FOLLOWING WAS CONFIRMED: SYSTEM SERIAL #, EVENT DATE, AND PROCEDURE NAME/CATEGORY. THE INTUITIVE TECH SUPPORT ENGINEER REVIEWED THE ONSITE LOGS AND FOUND THAT THE TRUMPF TABLE WAS POWERED DOWN DURING THE PROCEDURE. THIS COMPLAINT IS REPORTABLE DUE TO THE FOLLOWING: THE CUSTOMER CONVERTED AFTER THE START OF THE PROCEDURE DUE TO THE PRESENCE OF SMOKE IN THE OPERATING ROOM. 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. AT THIS TIME, THE SOURCE OF THE SMOKE HAS NOT BEEN IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LOW ANTERIOR RESECTION SURGICAL PROCEDURE THAT SMOKE WAS NOTICED IN THE OPERATING ROOM. THE STAFF BELIEVED THE SMOKE CAME FROM THE TRUMPF TABLE. THE INTUITIVE TECH SUPPORT ENGINEER (TSE) VIEWED THE LOGS, WHICH REFLECTED THAT THE TRUMPF TABLED POWERED OFF DURING THE PROCEDURE. THE REPORTER EXPLAINED THE SURGEON PROCEEDED TO A STOPPING POINT IN THE PROCEDURE, AND MOVED THE PROCEDURE TO A NEW ROOM AND NEW BED. THE REPORTER WAS UNCERTAIN OF HOW THE PROCEDURE PROCEEDED IN THE NEW ROOM. THE STAFF CONTACTED TRUMPF DIRECTLY TO REPORT THE ISSUE. THE SITE CALLED BACK AT A LATER TIME AND STATED THAT THE ROOM WHERE THE SMOKE OCCURRED WOULD BE DOWN UNTIL THE DA VINCI SYSTEM AND THE OTHER EQUIPMENT IN THE ROOM WAS CHECKED. THE CALLER STATED THAT THE TRUMPF TABLE HAD BEEN INSPECTED AND NO ISSUES WERE FOUND. THE BOOM AND OVERHEAD LIGHTS WERE REPORTEDLY INSPECTED AS WELL, WITH NO PROBLEMS FOUND. THE CALLER STATED THAT THE SMOKY SMELL WAS STILL LINGERING IN THE ROOM AND THAT THE DA VINCI SYSTEM WAS STILL IN THE ROOM AS WELL. THE TSE SUGGESTED MOVING THE SYSTEM TO A NEW ROOM TO SEE IF THE SMELL WOULD STAY PRESENT; THE CALLER DECLINED. THE TSE RECOMMENDED POWERING DOWN ALL OF THE SYSTEM COMPONENTS, SINCE THE CUSTOMER WAS NOT SURE IF THE SYSTEM WAS STILL RUNNING ON AC POWER. THE TSE RECOMMENDED THAT THE CUSTOMER CALL BACK FOR GUIDANCE ON HOW TO CORRECTLY REMOVE ALL THE POWER FROM THE PATIENT SIDE CART (PSC) SO THE BATTERY CHARGE DOES NOT DEPLETE. AN INTUITIVE FIELD SERVICE ENGINEER WAS REQUESTED FOR FOLLOW UP. THERE WERE NO REPORTS OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2040041 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-29 N/A 00886874110898

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male DA VINCI INSTRUMENTS AND ACCESSORIES