BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI SI

    MDR report key: 8039137 · Received November 5, 2018

    Report

    Report Number
    2955842-2018-10646
    Event Type
    Malfunction
    Date Received
    November 5, 2018
    Date of Event
    October 11, 2018
    Report Date
    October 11, 2018
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K081137
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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 INVESTIGATION CONFIRMED THE REPORTED COMPLAINT. VISUAL INSPECTION FOUND THE FAN DIRTY AND THE AC FUSE WAS GOOD. THE ILLUMINATOR WAS INSTALLED IN A TEST SYSTEM AND FAILED TO POWER UP. 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, AN ERROR 297 OCCURRED AND THE ILLUMINATOR LAMP WOULDN¿T TURN ON AND THE LED INDICATOR IN FRONT OF THE ILLUMINATOR WAS OFF. AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) REVIEWED THE LOG FILES AND NOTED ERRORS 48238 AND 297. THE TSE ADVISED TO POWER CYCLE, HOWEVER, THE ERRORS PERSISTED. THE SURGEON MADE THE DECISION TO CONTINUE WITH AN EXTERNAL ILLUMINATOR TO COMPLETE THE PROCEDURE AND NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED. AN ISI FIELD SERVICE ENGINEER WAS DISPATCHED TO THE FACILITY AND REPLACED THE ILLUMINATOR TO RESOLVE THE ISSUE. THE ILLUMINATOR CONTAINS A HIGH-INTENSITY LIGHT SOURCE TO ILLUMINATE THE SURGICAL SITE AND THE ELECTRONICS FOR INITIAL PROCESSING OF ENDOSCOPIC VIDEO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    878497 DAVINCI SI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 380990-11

    Patients

    Seq Age Sex Outcome Treatment
    1