BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI SI

    MDR report key: 8190267 · Received December 21, 2018

    Report

    Report Number
    2955842-2018-10777
    Event Type
    Malfunction
    Date Received
    December 21, 2018
    Date of Event
    November 29, 2018
    Report Date
    November 29, 2018
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K081137
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 ABLE TO REPRODUCE THE CUSTOMER REPORTED FAILURE MODE. THE ILLUMINATOR WAS INSTALLED INTO A TEST SYSTEM AND IT FAILED INTERMITTENTLY AT POWER UP WITH ERROR 48238 (COMMUNICATIONS ERROR). 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 SURGICAL PROCEDURE, THERE WAS NO ILLUMINATION FROM THE CAMERA HEAD. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) INSTRUCTED THE CUSTOMER TO CHECK THE GUIDE CABLE AND CHECK THE CONNECTION. THE CUSTOMER CONFIRMED THAT THE LIGHT GUIDE WAS FULLY SEATED AND DID NOT HAVE ANY PHYSICAL DAMAGE. THE TSE ADVISED THE CUSTOMER TO USE A THIRD PARTY LIGHT SOURCE. THE CUSTOMER USED A THIRD PARTY LIGHT SOURCE TO CONTINUE AND COMPLETE THE PROCEDURE. THERE WAS NO REPORT PATIENT HARM, ADVERSE OUTCOME OR INJURY. AN ISI FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE SITE AND REPLACED THE ILLUMINATOR TO RESOLVE THE ISSUE. 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
    1030146 DAVINCI SI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 380690-03

    Patients

    Seq Age Sex Outcome Treatment
    1