BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DA VINCI SI SURGICAL SYSTEM

    MDR report key: 7063562 · Received November 28, 2017

    Report

    Report Number
    2955842-2017-00795
    Event Type
    Malfunction
    Date Received
    November 28, 2017
    Date of Event
    November 1, 2017
    Report Date
    November 1, 2017
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K081137
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE UNIT FOR FAILURE ANALYSIS. THE REPORTED FAILURE COULD NOT BE REPLICATED, BUT WAS CONFIRMED VIA THE ERROR LOGS. THE ERROR EXPERIENCED BY THE CUSTOMER WAS A COMMUNICATION FAILURE. THE UNIT WAS INSTALLED ON PRINTED CIRCUIT ASSEMBLY (PCA) SYSTEM AND IT POWERED UP ON VISION SIDE CART (VSC) WITH NO ERRORS. THE UNIT WAS FOUND TO BE NO TROUBLE FOUND. THIS 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 THIS MALFUNCTION WERE TO RECUR IT COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED HYSTERECTOMY PROCEDURE, THE SITE EXPERIENCED A NON-RECOVERABLE FAULT AND THE ILLUMINATOR WOULD NOT TURN ON. THE SITE ATTEMPTED TO POWER CYCLE THE SYSTEM WITH NO CHANGE. THE CUSTOMER LOCATED AN ALTERNATE LIGHT SOURCE AND INSTALLED THE LIGHT GUIDE FROM THE SYSTEM. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE LIGHT SOURCE. THERE WAS NO REPORT OF PATIENT HARM, ADVERSE OUTCOME OR INJURY. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE FACILITY AND CONFIRMED THE ISSUE VIA THE LOGS. TO RESOLVE THE ISSUE THE FSE REPLACED THE ILLUMINATOR. 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
    844622 DA VINCI SI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS3000.A60P9B

    Patients

    Seq Age Sex Outcome Treatment
    1