BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISE BIPOLAR CAUTERY INSTRUMENT

    MDR report key: 1133418 · Received August 22, 2008

    Report

    Report Number
    2955842-2008-01223
    Event Type
    Malfunction
    Date Received
    August 22, 2008
    Report Date
    August 22, 2008
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    NAY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING CONDUCTED PERFORMANCE TESTS AND FOUND THE INSTRUMENT MOVED INTUITIVELY WITH FULL RANGE OF MOTION IN ALL DIRECTIONS. THE SYSTEM SUCCESSFULLY RECOGNIZED THE INSTRUMENT AND THE GRIPS OPENED AND CLOSED PROPERLY. ENGINEERING ALSO OBSERVED THE DISTAL END OF THE MAIN TUBE HAS A FEW DEEP SCRATCHES WITH MATERIAL REMOVED. THERE IS A .250" LONG SCRATCH ACROSS THE TUBE AND A SECTION 90 DEGREES APART WITH A FEW SCRATCHES THAT ARE PARALLEL TO THE TUBE AXIS. BASED ON THE LOCATION AND APPEARANCE, THE DAMAGE WAS MOST LIKELY CAUSED BY INSTRUMENT COLLISIONS. NO OTHER DAMAGE FOUND. THE ENDOWRIST INSTRUMENTS INSTRUCTIONS FOR USE (IFU) SPECIFICALLY STATES: GENERAL PRECAUTIONS AND WARNING: 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 PRECISE BIPOLAR CAUTERY INSTRUMENT IS DEFECTIVE. 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 PRECISE BIPOLAR CAUTERY INSTRUMENT ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL, INC. 420110-05 0607071 158

    Patients

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