BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DA VINCI SI SURGICAL SYSTEM

    MDR report key: 6861529 · Received September 13, 2017

    Report

    Report Number
    2955842-2017-00595
    Event Type
    Malfunction
    Date Received
    September 13, 2017
    Date of Event
    August 25, 2017
    Report Date
    August 25, 2017
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K081137
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INTUITIVE SURGICAL INC. (ISI) RECEIVED THE UNIT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS CONFIRMED THE CUSTOMER REPORTED FAILURE. DURING THE VIDEO TEST THERE WAS RIGHT IMAGE LOSS. THE ISSUE WAS CAUSED BY THE RIGHT CAMERA CONTROL UNIT (CCU). 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 TOTAL BENIGN HYSTERECTOMY PROCEDURE, THERE WAS VISION LOSS IN THE RIGHT EYE. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) ADVISED THE CUSTOMER TO ENSURE THE CABLE CONNECTIONS WERE TIGHT AND PERFORM A SYSTEM RESTART WITH BREAKER RESET; HOWEVER, THE ISSUE PERSISTED. THE TSE REVIEWED THE LOGS AND FOUND AN ERROR 48232 POINTING TO THE DUAL CAMERA CONTROLLER UNIT (DOCO). THE TSE HAD THE CUSTOMER REMOVE THE CAMERA CABLE FROM THE DOCO, POWER SYSTEM UP AND INSTALL A NEW CAMERA CABLE. THE ERROR 48232 RECURRED. THE SURGEON MADE THE DECISION TO CONVERT AND COMPLETE THE PROCEDURE AS A TRADITIONAL OPEN SURGICAL PROCEDURE. THERE WAS NO PATIENT HARM, ADVERSE OUTCOME OR INJURY REPORTED. AN ISI FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE FACILITY AND REPLACED THE DOCO TO RESOLVE THE 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
    642996 DA VINCI SI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS3000 A60P9B

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR