BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI SI

    MDR report key: 10547927 · Received September 17, 2020

    Report

    Report Number
    2955842-2020-10921
    Event Type
    Malfunction
    Date Received
    September 17, 2020
    Date of Event
    August 25, 2020
    Report Date
    August 25, 2020
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110683
    PMA / PMN Number
    K081137
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SG
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    4307- INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE HIGH RESOLUTION STEREO VIEWER MONITOR INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS FOUND THE LUMINANCE WAS OUT OF SPECIFICATION AS THERE WAS NO IMAGE IN THE INPUT FIBER OPTIC.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Additional Manufacturer Narrative · 1

    INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE FSE AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: NO ERRORS OCCURRED DURING SYSTEM POWER UP, SYSTEM FUNCTIONALITY, AND VISION WAS CHECKED AFTER POWER UP. THE FSE CONFIRMED NO ERRORS OCCURRED IN THE LOG FILES AND FULL TROUBLESHOOTING WAS COMPLETED. AFTER DOCKING, THE SURGEON IMMEDIATELY FOUND THE RIGHT EYE WAS BLACK WITH NO ERRORS; HOWEVER, THE SURGEON WENT INTO FOLLOWING MODE WITH ONLY LEFT EYE VISION. SINCE THE RIGHT MONITOR DID NO FUNCTION, 2D VISION WAS NOT AVAILABLE. NO PATIENT INJURY WAS REPORTED. THE HRSV HAS NOT BEEN RETURNED TO ISI FOR EVALUATION. THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT BE DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE INSTRUMENT IS RETURNED (POST ENGINEERING EVALUATION) OR IF ADDITIONAL INFORMATION IS RECEIVED. BASED ON THE INFORMATION PROVIDED AT THIS TIME, THIS COMPLAINT IS BEING REPORTED BECAUSE SYSTEM UNAVAILABILITY AFTER START OF A SURGICAL PROCEDURE (FIRST PORT INCISION) CONTRIBUTED TO THE PROCEDURE BEING ABORTED. ALTHOUGH NO PATIENT HARM OCCURRED, IF THIS MALFUNCTION WERE TO RECUR IT COULD POTENTIALLY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNSPECIFIED DA VINCI-ASSISTED PROSTATECTOMY SURGICAL PROCEDURE, THE SURGEON SIDE CONSOLE (SSC) RIGHT EYE WAS BLACK RIGHT AFTER DOCKING THE PATIENT SIDE CART TO THE PATIENT. A FIELD SERVICE ENGINEER (FSE) WAS ABLE TO ISOLATE THE ISSUE TO THE SSC RIGHT MONITOR. THE SURGEON MADE THE DECISION TO ABORT THE PROCEDURE POST ANESTHESIA AND PORT PLACEMENT WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1012907 DAVINCI SI SURGEON SIDE CONSOLE NAY INTUITIVE SURGICAL, INC 380610-21 N/A 00886874110683

    Patients

    Seq Age Sex Outcome Treatment
    1 DA VINCI INSTRUMENTS AND ACCESSORIES.| DA VINCI INSTRUMENTS AND ACCESSORIES