BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOPOLAR CURVED SCISSORS INSTRUMENT

    MDR report key: 1070073 · Received July 3, 2008

    Report

    Report Number
    2955842-2008-01131
    Event Type
    Malfunction
    Date Received
    July 3, 2008
    Report Date
    July 3, 2008
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING FOUND ONE GRIP CLOSE CABLE TO BE BROKEN AT THE SCISSOR GRIP AND DISTAL IDLERS. THE GRIP HUB HAS A PEAK ACROSS THE CABLE GROOVE THAT SHOULD HAVE BEEN MACHINED OFF BY THE SUPPLIER. THE CABLES WEAR AGAINST THIS PEAK LIKELY CONTRIBUTED TO THE BREAKAGE. THE SUPPLIER HAS BEEN INFORMED OF THIS ISSUE. ENGINEERING ALSO OBSERVED THE MAIN TUBE TO HAVE A 2" LONG SECTION NEAR THE MIDPOINT WITH LIGHT MATERIAL REMOVAL ON ONE SIDE OF THE TUBE. THE DAMAGED AREA IS PARALLEL TO THE TUBE AXIS AND HAS A ROUGH SURFACE FINISH. PART OF THE DAMAGED AREA IS ABOVE THE MIDPOINT, WHICH IS OUTSIDE THE RANGE OF MOTION OF THE DISTAL TIP OF THE CANNULA. THE SCRAPING MAY BE DUE TO TUBE PRESSURE AGAINST THE INTERNAL BOWL/TUBE INTERFACE OF THE CANNULA OR FROM ROUGH HANDLING DURING CLEANING PROCESS. 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 THAN 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 A WIRE AT THE WRIST OF THE MONOPOLAR CURVED SCISSORS INSTRUMENT HAD BROKEN. THE INSTRUMENT WAS REPLACED WITH AN INSTRUMENT OF THE SAME TYPE TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO PIECES OF THE INSTRUMENT HAD FALLEN INTO THE PATIENT. NO ADDITIONAL INFORMATION 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. 400179-08 1610071 999

    Patients

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