BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST PROGRASP INSTRUMENT

    MDR report key: 1063558 · Received June 20, 2008

    Report

    Report Number
    2955842-2008-01092
    Event Type
    Malfunction
    Date Received
    June 20, 2008
    Report Date
    June 20, 2008
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT ENGINEERING OBSERVED THAT THE DISTAL END OF THE MAIN TUBE HAS VARIOUS SCRATCH MARKS CONCENTRATED IN A 1.5 INCH LONG AREA, DIRECTLY ABOVE THE PROXIMAL CLEVIS. A COUPLE OF THE SCRATCH MARKS WERE DEEP AND HAD MATERIAL REMOVED. THE SCRATCHES ARE RANDOMLY ORIENTED RELATIVE TO THE TUBE AXIS, SUGGESTING THAT THEY WERE MOST LIKELY CAUSED BY INSTRUMENT COLLISIONS. CONCLUSIONS:THE ENDOWRIST INSTRUMENTS INSTRUCTIONS FOR USE (IFU) SPECIFICALLY STATES: GENERAL PRECAUTIONS AND WARNINGS. HANDLE 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 FIBERGLASS WAS COMING OFF THE ENDOWRIST PROGRASP INSTRUMENT. NOTHING WAS OBSERVED FALLING INTO THE PT. NO ADD'L INFO WAS PROVIDED. NO PT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOWRIST PROGRASP INSTRUMENT ENDOSCOPIC INSTRUMENT GCJ INTUITIVE SURGICAL, INC. 420093-07 0712132 815

    Patients

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