BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI SI

    MDR report key: 7967110 · Received October 15, 2018

    Report

    Report Number
    2955842-2018-10609
    Event Type
    Malfunction
    Date Received
    October 15, 2018
    Date of Event
    September 24, 2018
    Report Date
    September 24, 2018
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K081137
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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 WAS ABLE TO REPRODUCE THE CUSTOMER REPORTED FAILURE "THE LIGHT WOULD NOT TURN ON." FAILURE ANALYSIS PERFORMED VISUAL INSPECTION AND FOUND THE VENTILATION WINDOW HAD DUST STUCK ON AND THE FRONT PLASTIC HAD SCRATCHED PAINT. FAILURE ANALYSIS INSTALLED THE UNIT INTO PCA SYSTEM AND POWERED UP AND CONFIRMED THAT THE ILLUMINATOR FAILED WITH NO POWER AND ERROR 297 AND 48238 APPEARING AFTER SYSTEM BOOT UP. THE REPORTED FAILURE WAS REPLICATED. 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, THE ILLUMINATOR WOULD NOT TURN ON. THE CUSTOMER WAS UNABLE TO TURN THE ILLUMINATOR ON FROM EITHER THE VISION SIDE CART (VSC) MONITOR OR CAMERA HEAD EVEN THOUGH THE ILLUMINATOR LED WAS BLUE. AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) REVIEWED THE LOGS AND NOTED ERROR 48238, FOR AN ILLUMINATOR CONNECTION ERROR. THE TSE HAD THE CUSTOMER POWER OFF, CYCLE THE VSC CIRCUIT BREAKER AND AFTER TURNING THE SYSTEM BACK ON, THE ERROR 48238 RETURNED. THE TSE ATTEMPTED FURTHER TROUBLESHOOTING BUT THE ISSUE PERSISTED. THE TSE ADVISED THE CUSTOMER TO CONTINUE WITH ALTERNATE LIGHT SOURCE. THE PROCEDURE WAS COMPLETED WITH NO REPORT OF PATIENT HARM, ADVERSE OUTCOME OR INJURY. AN INTUITIVE SURGICAL INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO SITE TO ADDRESS THE REPORTED ISSUE. THE FSE REPLACED THE ILLUMINATOR TO RESOLVE THE ISSUE. 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
    805035 DAVINCI SI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 380625-04

    Patients

    Seq Age Sex Outcome Treatment
    1