BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI SI

    MDR report key: 8388642 · Received March 4, 2019

    Report

    Report Number
    2955842-2019-10159
    Event Type
    Malfunction
    Date Received
    March 4, 2019
    Date of Event
    July 23, 2018
    Report Date
    March 20, 2019
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K081137
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION CAN BE FOUND IN THE FOLLOWING SECTIONS: DATE OF REPORT, CONCOMITANT MEDICAL PRODUCTS , PMA/510K, AND IF FOLLOW-UP, WHAT TYPE. (B)(4) - THE ILLUMINATOR HAS BEEN RETURNED AND EVALUATED BY THE ORIGINAL EQUIPMENT MANUFACTURER (OEM). THE OEM CONFIRMED THE INITIAL REPORTED FAILURE. THE ILLUMINATOR FUSE WAS BLOWN AND WOULD NEED TO BE REPLACED. THERE WAS NO ADDITIONAL INFORMATION FOUND DURING OEM ANALYSIS.

    Description of Event or Problem · 0

    REFER TO ADDITIONAL FOR FOLLOW-UP INFORMATION.

    Additional Manufacturer Narrative · 1

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE PART INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS (FA) INVESTIGATION CONFIRMED AND REPLICATED THE REPORTED COMPLAINT. THE ILLUMINATOR WAS INSTALLED INTO A PCA TEST SYSTEM AND FAILED TO POWER ON WITH A 48238 ERROR. A VISUAL INSPECTION NOTED THE ILLUMINATOR HAD ONE BAD FUSE AND DUSTY FANS. 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 PROSTATECTOMY SURGICAL PROCEDURE, THERE WAS A NON-RECOVERABLE FAULT DURING A CASE. THE CUSTOMER WAS DOCKING INTO THE PATIENT. AN INTUITIVE SURGICAL INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) ASKED THE CUSTOMER TO VERIFY THE ILLUMINATOR, THE DOUBLE CAMERA CONTROLLER (DOCO) POWER SWITCHES, AND THE POWER CORDS WERE PLUGGED IN. THE TECHNICAL SUPPORT ENGINEER ASKED THE CUSTOMER TO DISCONNECT THE ILLUMINATOR TO DOCO COMMUNICATION CABLE. THE SYSTEM THEN POWERED UP AND HOMED SUCCESSFULLY; HOWEVER, WAS GETTING A RECOVERABLE FAULT 48238. THE CUSTOMER RECOVERED THE FAULT AND LOCATED THIRD PARTY ILLUMINATOR TO USE. THE CUSTOMER RE-INSTALLED THE INSTRUMENTS AND CONTINUED WITH THEIR CASE. THE PROCEDURE WAS COMPLETED 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 REPLACED THE ILLUMINATOR (B)(4) TO CORRECT THE REPORTED PROBLEM. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    180881 DAVINCI SI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 380990-09

    Patients

    Seq Age Sex Outcome Treatment
    1 DA VINCI INSTRUMENTS AND ACCESSORIES