BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DA VINCI XI SURGICAL SYSTEM

    MDR report key: 5318646 · Received December 22, 2015

    Report

    Report Number
    2955842-2015-01511
    Event Type
    Malfunction
    Date Received
    December 22, 2015
    Date of Event
    December 15, 2015
    Report Date
    December 15, 2015
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K131861
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE VIDEO PROCESSOR (VP) INVOLVED WITH THIS COMPLAINT. FAILURE ANALYSIS INSTALLED THE VP ON AN IN-HOUSE SYSTEM AND REPLICATED THE CUSTOMER REPORTED COMPLAINT. ALTHOUGH NO ERRORS CAME UP, THERE WAS NO VIDEO AND THE VP REMAINED POWERED OFF.

    Additional Manufacturer Narrative · 1

    AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL FIELD SPECIALIST (TFS) CONDUCTED ADDITIONAL INVESTIGATION OF THE SYSTEM ON SITE. TFS FOUND THE VIDEO PROCESSOR (VP) ASSEMBLY TO BE DEFECTIVE. THE TFS WILL REPLACE THE VP TO FIX THE REPORTED VISION ISSUE. THE PART HAVE NOT YET BEEN RECEIVED FOR EVALUATION BY INTERNAL FAILURE ANALYSIS. THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE HAS NOT BEEN DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE PRODUCT IS RETURNED AND EVALUATED AND/ OR IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO A DA VINCI COLECTOMY PROCEDURE, THERE WAS NO IMAGE AND A MESSAGE AUTO CHECK IN PROGRESS DISPLAYED. WHEN THE ENDOSCOPE WAS INSTALLED, A DIFFERENT MESSAGE NO IMAGE ON VISION SIDE CART (VSC) OR SURGEON SIDE CART (SSC), CHECK VIDEO PROCESSOR (VP) APPEARS. THE CUSTOMER CONTACTED INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT FOR ASSISTANCE. THE CUSTOMER WAS GUIDED THROUGH REBOOTING THE SYSTEM AND DIFFERENT TROUBLESHOOTING STEPS BUT THE ISSUE PERSISTED. THE SURGEON DECIDED TO CONVERT THE PLANNED PROCEDURE TO LAPAROSCOPY. ON DECEMBER 17, 2015, INTUITIVE SURGICAL, INC. (ISI) OBTAINED ADDITIONAL INFORMATION FROM THE REPORTER. THE PATIENT WAS ADMINISTERED AN EXTRA HOUR OF ANESTHESIA DUE TO THE SURGEON CONVERTING THE PROCEDURE TO LAPAROSCOPIC. THE CAMERA PORT WAS ALREADY PLACED WHEN THE SURGEON DECIDED TO CONVERT THE PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY OR HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    845524 DA VINCI XI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS4000 A7.0P4B

    Patients

    Seq Age Sex Outcome Treatment
    1