BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 8310569 · Received February 6, 2019

    Report

    Report Number
    2955842-2019-10085
    Event Type
    Malfunction
    Date Received
    February 6, 2019
    Date of Event
    January 18, 2019
    Report Date
    January 18, 2019
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K131861
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTUITIVE SURGICAL, INC. (ISI) WILL NOT BE RECEIVING THE FIBER OPTIC CABLE AS IT WAS SCRAPPED IN THE FIELD. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. THE 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 (FIRST PORT INCISION). ALTHOUGH NO PATIENT HARM OCCURRED, IF THE REPORTED MALFUNCTION WERE TO RECUR, IT COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED NEPHRECTOMY PROCEDURE (POST ANESTHESIA AND POST PORT INCISIONS), THE SYSTEM HAD 319 ERRORS DURING SETUP. AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) INSTRUCTED THE CLINICAL SALES REPRESENTATIVE (CSR) TO PERFORM AN EMERGENCY POWER OFF (EPO) ON THE PATIENT SIDE CART (PSC), HOWEVER, THE ISSUE PERSISTED. THE CSR WAS NOT SURE IF THE SURGEON WOULD ABORT TO ANOTHER DA VINCI SYSTEM OR ABORT TO A TRADITIONAL LAPAROSCOPIC PROCEDURE. THERE WAS NO REPORT OF PATIENT HARM, ADVERSE OUTCOME OR INJURY. INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE CSR AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SITE USED ANOTHER DA VINCI SYSTEM TO COMPLETE THE PROCEDURE. AN ISI FIELD SERVICE ENGINEER (FSE ) WAS DISPATCHED TO THE FACILITY AND WAS ABLE TO CONFIRMED THE REPORTED ISSUE VIA ERROR LOGS. THE FIBER OPTIC CABLE WAS REPLACED AND ISSUE WAS CLEARED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103911 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-36

    Patients

    Seq Age Sex Outcome Treatment
    1