BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOPOLAR CURVED SCISSORS INSTRUMENT

    MDR report key: 3203667 · Received July 3, 2013

    Report

    Report Number
    2955842-2013-02407
    Event Type
    Malfunction
    Date Received
    July 3, 2013
    Date of Event
    May 23, 2013
    Report Date
    June 6, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. ENGINEERING CONFIRMED THE REPORTED COMPLAINT. FOR CLARIFICATION, THE TUBE EXTENSION WAS FOUND BROKEN AT THE DISTAL END, AND THE BLADE TIPS WERE ALIGNED. THE TUBE EXTENSION WAS BROKEN AT THE PROXIMAL CLEVIS INTERFACE. THE CLEVIS WAS DISLODGED FROM THE TUBE EXTENSION. ENGINEERING CONCLUDED THE TUBE EXTENSION LIKELY BROKE DUE TO EXCESSIVE SIDE LOADING OR OTHER MISHANDLING. ADDITIONAL DAMAGE FOUND WAS DEEP SCRATCHES ON THE MAIN TUBE. THE DISTAL END OF THE MAIN TUBE HAD SCRATCH MARKS EXHIBITING LIGHT MATERIAL REMOVAL AND A ROUGH SURFACE FINISH. THE SCRATCHES VARIED IN LENGTH AND SOME WERE AXIALLY ALIGNED AND OTHERS WERE NOT AXIALLY ALIGNED WITH THE TUBE. ENGINEERING CONCLUDED THE DAMAGE MAY BE DUE TO MISHANDLING. ELECTRICAL CONTINUITY PASSED. 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. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER; TUBE ABRASIONS WITH MATERIAL REMOVAL , FOUND DURING FAILURE ANALYSIS EVALUATION COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF THE FAILURE MODE WERE TO RECUR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI SI TOTAL HYSTERECTOMY PROCEDURE A MONOPOLAR CURVED SCISSORS INSTRUMENT TIPS WERE NOT ALIGNED. THERE WERE NO MISSING PIECES OR FALLEN PIECES REPORTED. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED AND NO PATIENT HARM, ADVERSE OUTCOME, OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    305817 MONOPOLAR CURVED SCISSORS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420179-10 M13121219 498

    Patients

    Seq Age Sex Outcome Treatment
    1 DA VINCI SI SYSTEM INSTRUMENTS & ACCESSORIES ESU