BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DA VINCI SI SURGICAL SYSTEM

    MDR report key: 7223115 · Received January 26, 2018

    Report

    Report Number
    2955842-2018-00059
    Event Type
    Malfunction
    Date Received
    January 26, 2018
    Date of Event
    January 3, 2018
    Report Date
    January 3, 2018
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K081137
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE ILLUMINATOR INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS CONFIRMED THE CUSTOMER REPORTED FAILURE. A VISUAL INSPECTION WAS PERFORMED AND THE UNIT WAS FOUND IN GOOD CONDITION. THE UNIT WAS INSTALLED INTO A TEST SYSTEM AND AT START UP IT WAS CONFIRMED THAT THERE WAS NO POWER. 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 PARTIAL NEPHRECTOMY PROCEDURE, THE CUSTOMER HEARD A LOUD POPPING NOISE AND THEN THE SYSTEM FAULTED. THE CUSTOMER STATED THAT AFTER THE POP, THEY LOST THE LIGHT SOURCE ON THE SYSTEM. THE INTUITIVE SURGICAL INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) CONFIRMED THE ERROR 48238 IN THE SYSTEM LOGS. THE TSE WORKED WITH CUSTOMER TO DISABLE THE ILLUMINATOR AND BRING IN A THIRD PARTY LIGHT SOURCE. THE CUSTOMER WAS ABLE TO CONTINUE AND COMPLETE THE PROCEDURE USING THE THIRD PARTY LIGHT SOURCE. 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 FAILURE. THE FSE REMOVED AND REPLACED THE ILLUMINATOR. THE ILLUMINATOR IS A COMPONENT OF THE DA VINCI SYSTEM THAT CONTAINS A HIGH INTENSITY LIGHT SOURCE TO ILLUMINATE THE SURGICAL SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65881 DA VINCI SI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS3000 A60P6

    Patients

    Seq Age Sex Outcome Treatment
    1