BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOPOLAR CURVED SCISSORS INSTRUMENT

    MDR report key: 3103274 · Received May 9, 2013

    Report

    Report Number
    2955842-2013-01572
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    March 26, 2013
    Report Date
    April 9, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. ENGINEERING CONFIRMED THE REPORTED COMPLAINT WITH THE FOLLOWING CLARIFICATION: THE TUBE EXTENSION WAS BROKEN. THE INSTRUMENT WAS RETURNED WITH TIP COVER INSTALLED. THE TIP COVER EXHIBITED TEARING THAT EXPOSED THE PROXIMAL CLEVIS. THE TUBE EXTENSION WAS BROKEN AND MISSING A .210 X.150 PIECE AT THE PROXIMAL CLEVIS INTERFACE. THE CLEVIS WAS DISLODGED FROM TUBE EXTENSION. DISLODGMENT MAY MAKE REMOVAL OF INSTRUMENT FROM CANNULA DIFFICULT. THE TUBE EXTENSION FRACTURED NEXT TO ONE OF THE KEYS THAT MATES WITH THE PROX CLEVIS. ENGINEERING CONCLUDED THE TUBE EXTENSION LIKELY BROKE DUE TO EXCESSIVE SIDE LOADING OR OTHER MISHANDLING/MISUSE. ELECTRICAL CONTINUITY PASSED. NO OTHER DAMAGE WAS FOUND. ON (B)(4) 2013, ISI ATTEMPTED TO CONTACT THE INITIAL REPORTED OF THIS COMPLAINT TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. AT THE TIME OF THIS REPORT, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. 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; THE REPORTED MALFUNCTION IF TO RECUR COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI SI TOTAL HYSTERECTOMY, THE MONOPOLAR CURVED SCISSORS WERE BLOCKED. THE CUSTOMER ATTEMPTED TO MOVE WITH EMERGENCY GRIP RELEASE WITHOUT SUCCESS. THE SURGERY WAS STOPPED AND REMOVED WITH TROCARS. THERE WERE NO MISSING PIECES OR FALLEN PIECES REPORTED. NO PATIENT HARM, ADVERSE OUTCOME, OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203466 MONOPOLAR CURVED SCISSORS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420179-10 M10120912 033

    Patients

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