BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LARGE NEEDLE DRVIER ISNTRUMENT

    MDR report key: 1170806 · Received September 12, 2008

    Report

    Report Number
    2955842-2008-01269
    Event Type
    Malfunction
    Date Received
    September 12, 2008
    Report Date
    September 12, 2008
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING PLACED THE INSTRUMENT ON A TEST SYSTEM AND THE INSTRUMENT WAS INTERMITTENTLY RECOGNIZED. IT WAS DETERMINED THAT THE RECOGNITION ISSUE EXPERIENCED BY THE CUSTOMER WAS DUE TO THE PROGRAMMING ERROR OR A FAULTY RTI BOARD. ENGINEERING ALSO OBSERVED THE DISTAL END OF THE MAIN TUBE HAS A COUPLE OF SECTIONS WITH MATERIAL REMOVED DUE TO DEEP SCRATCHES. THE SCRATCHES ARE UNDER .250" LONG AND NOT ALIGNED WITH THE TUBE AXIS. BASED ON THE LOCATION AND APPEARANCE, THE DAMAGE WAS MOST LIKELY CAUSED BY INSTRUMENT COLLISIONS AND/OR ROUGH HANDLING. NO OTHER DAMAGE FOUND. THE ENDOWRIST INSTRUMENTS INSTRUCTIONS FOR USE (IFU) SPECIFICALLY STATES: GENERAL PRECAUTIONS AND WARNINGS. HANDLE INSTRUMENTS WITH CARE. AVOID MECHANICAL SHOCK OR STRESS THAT CAN CAUSE DAMAGE TO THE INSTRUMENTS. DO NOT USE AN INSTRUMENT TO CLEAN DEBRIS FROM ANOTHER INSTRUMENT INTRAOPERATIVELY. THIS MAY RESULT IN DAMAGE TO THE INSTRUMENTS OR OTHER UNINTENDED CONSEQUENCES, SUCH AS DISCONNECTION OF THE INSTRUMENT TIP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI S PROSTATECTOMY PROCEDURE THE LARGE NEEDLE DRIVER INSTRUMENT WAS NOT RECOGNIZED BY THE SYSTEM. NO ADDITIONAL INFO WAS PROVIDED. NO PT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LARGE NEEDLE DRVIER ISNTRUMENT ENDOSCOPIC INSTRUMENT GCJ INTUITIVE SURGICAL, INC 420006-05 081242 390

    Patients

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