BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DA VINCI SI SURGICAL SYSTEM

    MDR report key: 6004578 · Received October 6, 2016

    Report

    Report Number
    2955842-2016-00714
    Event Type
    Malfunction
    Date Received
    October 6, 2016
    Date of Event
    September 7, 2016
    Report Date
    September 7, 2016
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K081137
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ISI HAS RECEIVED THE DEVICE INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS INVESTIGATION WAS ABLE TO REPRODUCE THE CUSTOMER REPORTED FAILURE MODE FOR THE ILLUMINATOR. IT WAS INSTALLED AND TESTED ON AN IN-HOUSE TEST SYSTEM AND WOULD NOT POWER ON. THE FUSES WERE GOOD. FAILURE ANALYSIS INVESTIGATION WAS UNABLE TO REPRODUCE THE CUSTOMER REPORTED FAILURE MODE FOR THE DOUBLE CAMERA CONTROLLER (DOCO). IT WAS INSTALLED INTO PCA TEST SYSTEM AND RUNNING VIDEO TEST, WHITE BALANCE, CALIBRATION, 10 MINUTES SINE CYCLE, 10 POWER CYCLES & SITTING IDLE FOR 1 HOUR BUT NO TROUBLE WAS FOUND.

    Additional Manufacturer Narrative · 1

    THE UNITS HAVE NOT BEEN RETURNED TO ISI FOR EVALUATION. THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT BE DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE INSTRUMENT IS RETURNED (POST ENGINEERING EVALUATION) OR IF ADDITIONAL INFORMATION IS RECEIVED. 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, THE CUSTOMER EXPERIENCED A FAULT INDICATING A COMMUNICATION ISSUE. THE SYSTEM WAS RESTARTED AND A NON-RECOVERABLE FAULT WAS ONCE AGAIN ENCOUNTERED ALONG WITH AN ILLUMINATOR FAILURE. THE SURGEON MADE THE DECISION TO CONVERT AND COMPLETE THE SURGICAL PROCEDURE USING TRADITIONAL LAPAROSCOPIC TECHNIQUES. THERE WAS NO REPORT OF PATIENT HARM, ADVERSE OUTCOME OR INJURY. AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL FIELD SPECIALIST (TFS) WAS DISPATCHED TO THE FACILITY AND WAS ABLE TO REPRODUCE THE REPORTED FAILURE. THE TFS REPLACED THE ILLUMINATOR AND THE DOUBLE CAMERA CONTROLLER (DOCO) TO RESOLVE THE REPORTED ISSUE. THE ILLUMINATOR CONTAINS A HIGH-INTENSITY LIGHT SOURCE TO ILLUMINATE THE SURGICAL SITE AND THE ELECTRONICS FOR INITIAL PROCESSING OF ENDOSCOPIC VIDEO. THE DOCO IS LOCATED ON THE VISION SIDE CART AND IT RECEIVES AND PROCESSES VIDEO SIGNALS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661566 DA VINCI SI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS3000 A60P9B

    Patients

    Seq Age Sex Outcome Treatment
    1