BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 17028208 · Received May 30, 2023

    Report

    Report Number
    2955842-2023-15173
    Event Type
    Malfunction
    Date Received
    May 30, 2023
    Date of Event
    October 6, 2021
    Report Date
    October 6, 2021
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    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 FSE REPLACED THE ORANGE FIBER CABLE PORT FOR BLUE FIBER, ON THE PATIENT SIDE CART (PSC), TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI RECEIVED THE CABLE INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS (FA) INVESTIGATION CONFIRMED AND REPLICATED THE CUSTOMER REPORTED COMPLAINT. FA INSTALLED THE CABLE INTO AN IN-HOUSE PRINTED CIRCUIT ASSEMBLY (PCA) SYSTEM AND IT FAILED TO POWER UP, WITH AN ERROR 55 NOTED. FA NOTED THE ROOT CAUSE WAS ATTRIBUTED TO A COMPONENT FAILURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SACROCOLPOPEXY W/ HYSTERECTOMY SURGICAL PROCEDURE, THE CUSTOMER HAD A BROKEN CABLE GOING TO THE ROBOT. THE CUSTOMER STATED THAT THEY REPLACED THE CABLE, BUT NOW THEY HAVE A RED LIGHT EMITTING DIODE (LED) NEXT TO THE BLUE FIBER CABLE, AND WAS GETTING A MESSAGE; STATING THE PATIENT SIDE CART (PSC) WAS NOT CONNECTED OR THE POWER WAS NOT POWERED-ON. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) RECOMMENDED THAT THE CUSTOMER RESEAT THE CABLES AND TO CLEAN THE CABLE ENDS AS WELL AS THE RECEPTACLE. THE CUSTOMER STATED THAT THE CABLE WAS RUNNING FROM THE VISION TOWER TO THE WALL. THE TSE RECOMMENDED THAT THEY TAKE THE CABLE FROM THE ROBOT DIRECTLY TO THE VISION TOWER. THE CUSTOMER DID AS INSTRUCTED AND THE ISSUE REMAINED. THE CUSTOMER STATED THAT THEY SWAPPED VISION TOWER PORTS. THE TSE RECOMMENDED THAT THEY POWER-CYCLE, BUT THE CUSTOMER WAS UNABLE TO DO SO AT THAT TIME. THE CUSTOMER CONVERTED TO GENERAL LAPAROSCOPIC AND WAS USING THE VISION TOWER SCOPE. THE CUSTOMER WAS TO CALL BACK AFTER THE CASE TO TROUBLESHOOT. THE PROCEDURE WAS CONVERTED TO A LAPAROSCOPIC SURGERY WITH NO REPORTED PATIENT HARM, INJURY, OR ADVERSE OUTCOME. THE CUSTOMER FOLLOWED UP AND EXPLAINED THAT THEY HAD POWER-CYCLED, BUT THE ISSUE WAS STILL PRESENT. THE OPERATING ROOM (OR) NURSE REPORTED THEY HAD PLACED THE BREAKER TO THE VISION SIDE CART (VSC) AND THE PSC TO THE 'OFF' POSITION, BUT THEY DID NOT VERIFY THE SURGEON SIDE CONSOLE (SSC) POWER STATUS. THE TSE RECOMMENDED THE STAFF COMPLETE A POWER-CYCLE OF ALL THE COMPONENTS, USING THE BREAKERS AND THE PSC EMERGENCY POWER OFF (EPO). THE TSE RECOMMENDED WHILE ALL COMPONENTS ARE POWERED OFF, THE STAFF VERIFY THE FIBER CABLES WERE FULLY SEATED BY GENTLY PULLING ON THE CABLES AND ENSURING THEY DID NOT PULL OUT. AFTER ENSURING ALL THE FIBER CABLES WERE FULLY SEATED, THE TSE RECOMMENDED THE STAFF TO RESTORE POWER TO THE COMPONENTS. THE STAFF WAS TO COMPLETE THE HARD POWER-CYCLE OF THE SYSTEM AND ENSURE THE CABLES WERE SEATED AFTER THE COMPLETION OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1029572 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-22 N/A

    Patients

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