BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DA VINCI SI SURGICAL SYSTEM

    MDR report key: 7108830 · Received December 12, 2017

    Report

    Report Number
    2955842-2017-00833
    Event Type
    Malfunction
    Date Received
    December 12, 2017
    Date of Event
    November 15, 2017
    Report Date
    November 15, 2017
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K081137
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DOCO WAS RETURNED FOR EVALUATION. FAILURE ANALYSIS CONFIRMED THE CUSTOMER REPORTED COMPLAINT. VISUAL INSPECTION FOUND THAT THE CENTER PIN OF THE RIGHT CAMERA CONTROL UNIT (CCU) WAS BENT. THE RIGHT CCU WILL BE REPLACE TO REPAIR THE DOCO. 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 SURGEON EXPERIENCED VIDEO LOSS IN THE RIGHT EYE OF THE HIGH RESOLUTION STEREO (HRSV) VIEWER AFTER REPLACING THE ILLUMINATOR. THE CUSTOMER CHECKED TO ENSURE THAT THE CAMERA CABLE WAS SECURE, PERFORMED A CYCLE POWER OF THE SYSTEM, AND REPLACED THE CAMERA HEAD; HOWEVER, THE ISSUE PERSISTED. DUE TO THE REPORTED VISION ISSUE, THE SURGEON MADE THE DECISION TO COMPLETE THE PLANNED SURGICAL PROCEDURE USING TRADITIONAL LAPAROSCOPIC TECHNIQUES. 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 CUSTOMER REPORTED COMPLAINT. THE FSE FOUND THAT THE CENTER PIN IN THE RIGHT EYE VIDEO CONNECTION OF THE DOUBLE CAMERA CONTROLLER (DOCO) WAS BENT. THE FSE REPLACED THE DOCO TO RESOLVE THE REPORTED VISION LOSS ISSUE. THE DOCO IS LOCATED ON THE VSC AND IT RECEIVES AND PROCESSES VIDEO SIGNALS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    889832 DA VINCI SI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS3000 A70.P7B

    Patients

    Seq Age Sex Outcome Treatment
    1