BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 9723189 · Received February 18, 2020

    Report

    Report Number
    2955842-2020-10118
    Event Type
    Malfunction
    Date Received
    February 18, 2020
    Date of Event
    January 24, 2020
    Report Date
    January 24, 2020
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K131861
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    4307 - INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE HIGH RESOLUTION STEREO VIEWER (HRSV) MONITOR INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS INVESTIGATION REPLICATED AND CONFIRMED THE CUSTOMER REPORTED COMPLAINT. THE HRSV MONITOR WAS OBSERVED TO HAVE NO IMAGE, INDICATING A DEFECTIVE MAIN BOARD.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 1

    AN ISI FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED COMPLAINT. THE FSE WAS ABLE TO REPRODUCE THE REPORTED ISSUE. THE FSE SWAPPED THE DIGITAL VIDEO INTERFACE (DVI) LEADS BETWEEN THE LEFT AND THE RIGHT HIGH RESOLUTION STEREO VIEWER (HRSV) MONITORS AND VERIFIED THE PROBLEM DID NOT FOLLOW. THE FSE REPLACED THE AFFECTED MONITOR TO CORRECT THE REPORTED ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. THE HRSV WAS RETURNED TO INTUITIVE SURGICAL, INC. (ISI) FOR FAILURE ANALYSIS EVALUATION. HOWEVER, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT BE DETERMINED AS FAILURE ANALYSIS INVESTIGATION IS IN PROGRESS. A FOLLOW-UP MDR WILL BE SUBMITTED UPON THE COMPLETION OF THE FAILURE ANALYSIS AND/OR IF ADDITIONAL INFORMATION IS RECEIVED. BASED ON THE INFORMATION PROVIDED AT THIS TIME, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: SYSTEM UNAVAILABILITY AFTER START OF A SURGICAL PROCEDURE (FIRST PORT INCISION) COULD LEAD TO THE PROCEDURE TO BE CONVERTED/ABORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED INGUINAL HERNIA REPAIR SURGICAL PROCEDURE, THE LEFT EYE OF THE SURGEON SIDE CONSOLE (SSC) WAS BLACK. THE SITE HAD RESTARTED THE SYSTEM WITH NO RESOLUTION. THE TECHNICAL SUPPORT ENGINEER (TSE) HAD THE SITE PERFORM TWO HARD RESTARTS WITH NO SUCCESS. THE SITE STATED THAT THEY WOULD TRY TO COMPLETE THE SURGERY WITH ONE EYE ON THE SSC, OR THEY MAY CONVERT TO LAPAROSCOPIC SURGERY. INTUITIVE SURGICAL, INC. (ISI) OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: THE PROCEDURE WAS NOT CONVERTED TO LAPAROSCOPIC SURGERY. THE SURGEON COMPLETED THE PROCEDURE ROBOTICALLY USING THE SSC WITH ONE EYE, AND THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182786 DAVINCI XI SURGEON SIDE CONSOLE, SMART PEDALS NAY INTUITIVE SURGICAL, INC 380677-15

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR DA VINCI INSTRUMENTS AND ACCESSORIES