BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI SURGICAL SYSTEM

    MDR report key: 1002915 · Received February 11, 2008

    Report

    Report Number
    2955842-2008-00055
    Event Type
    Other
    Date Received
    February 11, 2008
    Date of Event
    January 17, 2008
    Report Date
    February 8, 2008
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    NAY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ON SITE INVESTIGATION AND EVALUATION WAS CONDUCTED BY FIELD SERVICE ENGINEERING. SYSTEM VERIFICATION TESTS WERE PERFORMED AND THE CUSTOMER REPORTED FAILURE MODE COULD NOT BE DUPLICATED. THE RIGHT PT SIDE MANIPULATOR (PSM) WAS REPLACED AS A PRECAUTION. THE PT SIDE MANIPULATOR IS AN INSTRUMENT ARM LOCATED ON THE PT SIDE CART WHICH PROVIDES THE STERILE INTERFACE FOR THE ENDOWRIST INSTRUMENTS. THE PSM WAS RETURNED TO ISI FOR FAILURE ANALYSIS INVESTIGATION. MECHANICAL AND ELECTRICAL PERFORMANCE TESTS WERE CONDUCTED AND THE CUSTOMER REPORTED FAILURE MODE COULD NOT BE REPRODUCED. 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 PROSTATECTOMY SURGICAL PROCEDURE, THE RIGHT SYSTEM ARM WAS NOT ALLOWING THE INSTRUMENT JAWS TO OPEN AND CLOSE PROPERLY, AND THE SURGEON FOUND IT DIFFICULT TO ARTICULATE THE JAWS DURING WRIST MOVEMENT. THE INSTRUMENT STERILE ADAPTER WAS REPLACED, HOWEVER, THESE ISSUES CONTINUED TO RECUR. NO PATIENT HARM WAS REPORTED. THE PROCEDURE WAS CONVERTED TO TRADITIONAL OPEN SURGICAL TECHNIQUES TO FINISH THE PLANNED SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DA VINCI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL, INC. IS12000 A4.3P8

    Patients

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