BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI SI

    MDR report key: 8741191 · Received June 27, 2019

    Report

    Report Number
    2955842-2019-10489
    Event Type
    Malfunction
    Date Received
    June 27, 2019
    Date of Event
    June 17, 2019
    Report Date
    June 17, 2019
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K081137
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE PARTS INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS INVESTIGATION CONFIRMED AND REPLICATED THE REPORTED COMPLAINT. A VISUAL INSPECTION FOUND THE ILLUMINATOR HAD A DIRTY FAN, A SCRATCH ON THE FRONT PANEL, AND A BAD FUSE. THE ILLUMINATOR WAS THEN INSTALLED INTO A TEST SYSTEM AND FAILED TO POWER ON THE VISION SIDE CART (VSC) WITH ERROR 48238/297 (COMMUNICATION ERROR). 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 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 DURING A DA VINCI-ASSISTED TOTAL BENIGN HYSTERECTOMY SURGICAL PROCEDURE, THE ILLUMINATOR LIGHT WENT OUT AND WOULD NOT TURN ON. THE CUSTOMER HAD ALREADY CHECKED THE LIGHT GUIDE SEATING, POWER CORD, AND COMMUNICATION CORD CONNECTION AS WELL AS POWER CYCLED THE ILLUMINATOR UNIT. THE ILLUMINATOR WOULD NOT RESPOND WHEN ATTEMPTING TO TURN ON THE LAMP. THE SYSTEM LOGS SHOWED THE ILLUMINATOR COMMUNICATION ERROR 48238. THE TECHNICAL SERVICE ENGINEER (TSE) RECOMMENDED SWITCHING TO AN ALTERNATE LIGHT SOURCE, AS QUICKEST RESOLUTION. THE CUSTOMER CONNECTED THEIR ILLUMINATOR LIGHT GUIDE INTO AN ALTERNATE LIGHT SOURCE AND CONTINUED WITH THE CASE. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED COMPLAINT. THE FIELD SERVICE ENGINEER (FSE) REPLACED THE ILLUMINATOR (951183-04) AND THE ILLUMINATOR TO DUAL CAMERA CONTROLLER (DOCO) CABLE (371816-01) TO RESOLVE THE REPORTED ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. THE AFFECTED PART(S) INVOLVED WITH THIS COMPLAINT IS A FIELD SCRAP ITEM AND WILL NOT BE RETURNING TO ISI FOR FURTHER INVESTIGATION. (371816-01)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    534343 DAVINCI SI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 380990-08

    Patients

    Seq Age Sex Outcome Treatment
    1