BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DA VINCI SI SURGICAL SYSTEM

    MDR report key: 7237470 · Received February 2, 2018

    Report

    Report Number
    2955842-2018-00074
    Event Type
    Malfunction
    Date Received
    February 2, 2018
    Date of Event
    January 11, 2018
    Report Date
    January 11, 2018
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K081137
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ISI RECEIVED THE UNIT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. THE FAILURE ANALYSIS CONFIRMED THE CUSTOMER REPORTED FAILURE. THE UNIT WAS INSTALLED INTO PCA TEST SYSTEM AND IT FAILED WITH AN ERROR 48230. THE ISSUE WAS CAUSED BY THE RIGHT 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 INGUINAL HERNIA REPAIR PROCEDURE, THE RIGHT EYE IN THE CONSOLE WENT OUT. THERE WERE NO ERRORS AND THE MONITOR IN THE CONSOLE WAS BLACK. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) SUGGESTED FOR THE CUSTOMER TO RESTART THE SYSTEM BUT THE CUSTOMER WAS UNABLE TO AT THE TIME. THERE WAS NO REPORT OF PATIENT HARM, ADVERSE OUTCOME OR INJURY. AN ISI FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE FACILITY AND WAS ABLE TO REPRODUCE THE REPORTED ISSUE. THE FSE REPLACED THE DOCO TO CORRECT THE ERROR 48230 AND THE RIGHT EYE GOING BLACK DURING THE PROCEDURE. 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
    81629 DA VINCI SI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS3000

    Patients

    Seq Age Sex Outcome Treatment
    1