BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DA VINCI SI SURGICAL SYSTEM

    MDR report key: 6710811 · Received July 13, 2017

    Report

    Report Number
    2955842-2017-00434
    Event Type
    Malfunction
    Date Received
    July 13, 2017
    Date of Event
    June 15, 2017
    Report Date
    June 15, 2017
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K081137
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE ILLUMINATOR INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS CONFIRMED THE CUSTOMER REPORTED FAILURE. A VISUAL INSPECTION WAS PERFORMED AND THE UNIT WAS FOUND IN GOOD CONDITION; ERROR 48238 WAS OBSERVED. THE UNIT WAS INSTALLED INTO A TEST SYSTEM AND AT START UP IT WAS CONFIRMED THAT THERE WAS NO POWER. THE AC FUSE WAS ALSO CHECKED AND ONE WAS BLOWN OFF. 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 VANCI-ASSISTED SURGICAL PROCEDURE, THE ILLUMINATOR LIGHT SHUT OFF AND THE FRONT PANEL LED'S WERE OFF. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) INSTRUCTED THE CUSTOMER TO CYCLE THE ILLUMINATOR POWER SWITCH. THE ILLUMINATOR REMAINED OFF AND THE CUSTOMER WAS UNABLE TO TURN IT ON USING THE CAMERA HEAD LIGHT SWITCH. THE SYSTEM EVENT LOGS SHOWED ERROR 48238 INDICATING LOSS OF ILLUMINATOR COMMUNICATION. THE CUSTOMER WAS RECOMMENDED TO USE AN ALTERNATE LIGHT SOURCE. THE CUSTOMER CONNECTED LIGHT GUIDE TO ANOTHER LAPAROSCOPIC LIGHT SOURCE TO COMPLETE THE PROCEDURE. 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 WAS ABLE TO REPRODUCE THE REPORTED FAILURE. THE FSE REMOVED AND 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
    492560 DA VINCI SI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS3000 A60P9B

    Patients

    Seq Age Sex Outcome Treatment
    1