BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI S SURGICAL SYSTEM

    MDR report key: 1061711 · Received June 13, 2008

    Report

    Report Number
    2955842-2008-01073
    Event Type
    Other
    Date Received
    June 13, 2008
    Date of Event
    May 19, 2008
    Report Date
    June 13, 2008
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    NAY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONDUCTED BY FIELD SERVICE ENGINEERING FOUND NO ERRORS IN THE DA VINCI S SYSTEM LOG. PERFORMANCE TESTS FOR THE SPECIFIC PT SIDE MANIPULATOR (PSM) ARM WERE CONDUCTED AND THE CUSTOMER REPORTED PROBLEM COULD NOT BE DUPLICATED. THE PT SIDE MANIPULATOR IS AN INSTRUMENT ARM LOCATED ON THE PT SIDE CART, THAT PROVIDES THE STERILE INTERFACE FOR THE ENDOWRIST INSTRUMENTS. ENGINEERING CONCLUDED THAT THE INSTRUMENT INSERTED IN THE PSM WAS MOST LIKELY AT THE END OF THE CANNULA ACCESSORY AND THE "JERKY" MOTION WAS DUE TO THIS POOR POSITIONING. AS OF 2008, THERE HAVE BEEN NO REPORTED RECURRENCES OF THE ISSUE AT THIS HOSPITAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI S BEATING HEART TECAB PROCEDURE, APPROX FIVE HOURS INTO THE PROCEDURE, THE SURGEON STATED THAT A PT SIDE MANIPULATOR (PSM) ARM FELT "JERKY". THE SITE CONVERTED TO TRADITIONAL OPEN SURGICAL TECHNIQUES TO FINISH THE PLANNED SURGERY. NO PT HARM WAS REPORTED. THE CUSTOMER CONTACTED ISI TECHNICAL SUPPORT AFTER THE PROCEDURE WAS COMPLETE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DA VINCI S SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL, INC. IS2000 A5.1P4

    Patients

    Seq Age Sex Outcome Treatment
    1 Other INSTRUMENTS| DA VINCI S SURGICAL SYSTEM| ACCESSORIES