BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DA VINCI SI SURGICAL SYSTEM

    MDR report key: 6540454 · Received May 3, 2017

    Report

    Report Number
    2955842-2017-00267
    Event Type
    Malfunction
    Date Received
    May 3, 2017
    Date of Event
    April 11, 2017
    Report Date
    April 11, 2017
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K081137
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTUITIVE SURGICAL INC. (ISI) RECEIVED THE ILLUMINATOR INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS WAS NOT ABLE TO CONFIRM THE REPORTED COMPLAINT. A VISUAL INSPECTION WAS PERFORMED AND FOUND THE FRONT PANEL COVER WAS BROKEN. THE ILLUMINATOR WAS INSTALLED INTO A PRINTED CIRCUIT ASSEMBLY SYSTEM AND THE IMAGE LOOKED OK. NO ISSUES WERE FOUND DURING A SYSTEM POWER CYCLE OR WITH THE LIGHT IMAGE. 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 SURGICAL PROCEDURE, THE ILLUMINATOR LIGHT WAS FLASHING ON AND OFF. THE INTUITIVE SURGICAL INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) INSTRUCTED THE CUSTOMER TO USE AN ALTERNATE LIGHT SOURCE TO FINISH THE CASE. THE CUSTOMER USED A STORZ TOWER AS THEIR ALTERNATE LIGHT SOURCE AND COMPLETED 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 WAS UNABLE TO REPRODUCE THE REPORTED COMPLAINT. HOWEVER, A REVIEW OF THE SYSTEM LOGS DID CONFIRM AN ERROR HAD OCCURRED. 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
    322042 DA VINCI SI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS3000 A60P9B

    Patients

    Seq Age Sex Outcome Treatment
    1