BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DA VINCI SI SURGICAL SYSTEM

    MDR report key: 7544359 · Received May 25, 2018

    Report

    Report Number
    2955842-2018-10232
    Event Type
    Malfunction
    Date Received
    May 25, 2018
    Date of Event
    April 30, 2018
    Report Date
    April 30, 2018
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE ILLUMINATOR ASSOCIATED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS CONFIRMED THE REPORTED ISSUE OF "SITE WAS UNABLE TO WHITE BALANCE". VISUAL INSPECTION OF THE UNIT FOUND THAT FANS WERE DUSTY. THE UNIT WAS INSTALLED INTO PRINTED CIRCUIT ASSEMBLY TEST SYSTEM AND THE UNIT FAILED TO WHITE BALANCE. THE COMPLAINT IS BEING REPORTED DUE TO A DA VINCI SYSTEM MALFUNCTION RENDERING THE DA VINCI SYSTEM UNAVAILABLE FOR USE AFTER THE START OF A SURGICAL PROCEDURE. ALTHOUGH NO PATIENT HARM OCCURRED, IF THE REPORTED MALFUNCTION WERE TO RECUR, IT COULD CAUSE OR IT COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED TOTAL BENIGN HYSTERECTOMY PROCEDURE, THE SITE WAS UNABLE TO WHITE BALANCE USING THE FLUORESCENCE ILLUMINATOR. THE INTUITIVE SURGICAL INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) HAD THE CUSTOMER VERIFY THAT LIGHT GUIDE CONNECTION WAS SECURE, BUT WHITE BALANCE ISSUES PERSISTED ON MULTIPLE ENDOSCOPES. THE SITE WAS FINALLY ABLE TO WHITE BALANCE WITH AN EXTERNAL LIGHT SOURCE AND COMPLETE THE PROCEDURE ROBOTICALLY. THERE WAS NO REPORT OF PATIENT HARM, ADVERSE OUTCOME, OR INJURY. AN ISI FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE FACILITY AND REPLACED THE ILLUMINATOR TO RESOLVE THE WHITE BALANCE FAILURES THE SITE ENCOUNTERED. THE ILLUMINATOR IS A COMPONENT OF THE DA VINCI SYSTEM THAT CONTAINS A HIGH INTENSITY LIGHT SOURCE TO ILLUMINATE THE SURGICAL SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389013 DA VINCI SI SURGICAL SYSTEM VISION SIDE CART NAY INTUITIVE SURGICAL, INC 380625-04

    Patients

    Seq Age Sex Outcome Treatment
    1