BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MARYLAND BIPOLAR FORCEPS INSTRUMENT

    MDR report key: 1810366 · Received August 20, 2010

    Report

    Report Number
    2955842-2010-00379
    Event Type
    Malfunction
    Date Received
    August 20, 2010
    Report Date
    July 21, 2010
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K012833
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. ENGINEERING WAS UNABLE TO CONFIRM THE CUSTOMER REPORTED FAILURE MODE AS THE INSTRUMENT PASSED RECOGNITION AND ENGAGEMENT TESTING. ADDITIONAL FUNCTIONAL TESTING REVEALED THAT THE INSTRUMENT MOVED INTUITIVELY WITH A FULL RANGE OF MOTION IN ALL DIRECTIONS AND THE GRIPS OPENED AND CLOSED PROPERLY. THERE WAS NO EXCESSIVE FRICTION IN ANY AXIS OF MOTION. ENGINEERING ALSO OBSERVED CHARRING ON THE YAW PULLEY AND TUBE DAMAGE. THE OUTER SURFACE OF THE YAW PULLEY COVER EXHIBITS A CHAR MARK AND LOCALIZED MELTING/THERMAL DAMAGE, INDICATING THAT AN ARCING EVENT OCCURRED. THERE IS NO CHARRING BETWEEN THE GRIPS OR THE YAW PULLEY. THE CHAR MARK POSITION MAY INDICATE UNINTENDED CURRENT FLOWED TO THE YAW PULLEY COVER. THE DISTAL END OF THE MAIN TUBE HAS A 1.8 LONG SECTION WITH LIGHT MATERIAL REMOVAL AND HAS A ROUGH SURFACE FINISH. THE DAMAGED AREA IS AXIALLY ALIGNED WITH THE TUBE. NO OTHER DAMAGE WAS FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI S PROSTATECTOMY PROCEDURE, THE MARYLAND BIPOLAR INSTRUMENT WAS STIFF AND HARD TO MOVE. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED. THE CUSTOMER REPORTED MALFUNCTION DOES NOT IN ITSELF CONSTITUTE A REPORTABLE EVENT, HOWEVER, DURING INTERNAL EVALUATION OF THE INSTRUMENT, ENGINEERING DISCOVERED EVIDENCE THAT AN ARCING EVENT MAY HAVE OCCURRED DURING THE SURGICAL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MARYLAND BIPOLAR FORCEPS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420172-06 M10091130 876

    Patients

    Seq Age Sex Outcome Treatment
    1 DA VINCI S SURGICAL SYSTEM, ACCESSORIES AND AN ES