BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOPOLAR CURVED SCISSORS INSTRUMENT

    MDR report key: 1001759 · Received February 19, 2008

    Report

    Report Number
    2955842-2008-00063
    Event Type
    Malfunction
    Date Received
    February 19, 2008
    Date of Event
    January 15, 2008
    Report Date
    February 19, 2008
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING PERFORMED FUNCTIONAL TESTING AND FOUND THE INSTRUMENT TO MOVE INTUITIVELY WITH A FULL RANGE OF MOTION IN ALL DIRECTIONS. THE JAWS OPENED AND CLOSED FINE. THE INSTRUMENT WAS PLACED ON THE SYSTEM FOR A LATEX CUT TEST. THE SCISSORS DO NOT CUT CLEANLY THROUGH .006" LATEX. THE LATEX GETS SNAGGED AT SCISSOR TIPS. ONE BLADE EXHIBITS PITTING. ENGINEERING ALSO OBSERVED THE DISTAL END OF THE MAIN TUBE TO HAVE A COUPLE OF DEEP SCRATCH MARKS WITH MATERIAL REMOVED. THE SCRATCHES ARE LOCATED ON ONE SIDE OF THE TUBE AND ARE NOT PARALLEL TO THE TUBE AXIS, SUGGESTING THEY WERE CAUSED BY INSTRUMENT COLLISIONS. 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 THE JAWS OF THE MONOPOLAR CURVED SCISSORS INSTRUMENT DO NOT OPEN. IT WAS REPORTED THAT THE PATIENT WAS NOT IMPACTED. NO ADDITIONAL INFORMATION WAS PROVIDED. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MONOPOLAR CURVED SCISSORS INSTRUMENT ELECTROSURGICAL INSTRUMENT GEI INTUITIVE SURGICAL, INC. 420179-08 1608071 145

    Patients

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