BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MARYLAND BIPOLAR FORCEPS INSTRUMENT

    MDR report key: 2993616 · Received March 7, 2013

    Report

    Report Number
    2955842-2013-00767
    Event Type
    Malfunction
    Date Received
    March 7, 2013
    Date of Event
    January 2, 2013
    Report Date
    February 5, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. ENGINEERING WAS UNABLE TO CONFIRM THE CUSTOMER REPORTED FAILURE MODE AS FUNCTIONAL TESTING OF THE INSTRUMENT ON AN IS3000 IN-HOUSE SYSTEM FOUND THAT THE INSTRUMENT WAS SUCCESSFULLY RECOGNIZED AND THE INSTRUMENT PASSED CAUTERY TESTING WITH SMOKE COMING FROM A WET PAPER TOWEL. THE POGO PINS DO NOT STICK, AND THERE WERE NO SIGNS OF DAMAGE TO THE DALLAS CHIP, BIPOLAR PINS, OR CONDUCTOR WIRE. THE INSTRUMENT ALSO PASSED ELECTRICAL CONTINUITY TESTING. ENGINEERING EVALUATION ALSO FOUND THAT THE DISTAL END OF THE MAIN TUBE EXHIBITS SCRATCHES. FROM THE PROXIMAL END TO APPROXIMATLY 3 IN, THERE ARE SEVERAL DEEP SCRATCHES, LEAVING A ROUGH SURFACE. ENGINEERING CONCLUDED THAT THE DAMAGE TO THE MAIN TUBE IS LIKELY DUE TO MISHANDLING. NO OTHER DAMAGE WAS FOUND. THE INSTRUMENTS AND ACCESSORIES USER MANUAL 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 FAILURE ANALYSIS FINDING DOES NOT CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER; THE DAMAGE TO THE INSTRUMENT'S MAIN TUBE, COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF THE MALFUNCTION WERE TO RECUR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO STARTING A DA VINCI S SURGICAL PROCEDURE, THE MARYLAND BIPOLAR FORCEPS INSTRUMENT WOULD NOT ENERGIZE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97937 MARYLAND BIPOLAR FORCEPS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420172-06 2906071 826

    Patients

    Seq Age Sex Outcome Treatment
    1 DA VINCI S SYS., INSTRUMENTS, ACCESSORIES & ESU.