BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FENESTRATED BIPOLAR FORCEPSINSTRUMENT

    MDR report key: 2832460 · Received November 14, 2012

    Report

    Report Number
    2955842-2012-00911
    Event Type
    Malfunction
    Date Received
    November 14, 2012
    Date of Event
    September 28, 2012
    Report Date
    October 17, 2012
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING OBSERVED THAT THE BIPOLAR INSERT IS MISSING FROM BACK END. THE PINS AND CONDUCTOR WIRES ARE STICKING OUT OF THE CHASSIS. THE INSERT MAY HAVE NOT BEEN FULLY SEATED IN CHASSIS OR MAY HAVE BEEN PULLED OUT WHEN THE BIPOLAR CORD WAS REMOVED. THE INSTRUMENT PASSED ELECTRICAL CONTINUITY TESTING. ENGINEERING EVALUATION ALSO FOUND THAT THE DISTAL END OF THE MAIN TUBE HAS A 1.85 LONG SECTION WITH MATERIAL REMOVED ON ONE SIDE OF THE TUBE. THE DAMAGED AREA IS PARALLEL TO TUBE AXIS AND HAS A ROUGH SURFACE FINISH. ENGINEERING CONCLUDED THAT THE DAMAGE TO THE MAIN TUBE WAS LIKELY DUE TO MISHANDLING OR MISUSE. NO OTHER DAMAGE WAS FOUND. THE INSTRUMENTS AND ACCESSORIES USER MANUAL SPECIFICALLY STATES: GENERAL PRECAUTIONS AND WARNINGS,, O HANDLE INSTRUMENTS WITH CARE. AVOID MECHANICAL SHOCK OR STRESS THAT CAN CAUSE DAMAGE TO THE INSTRUMENTS. O 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 DAMAGE TO THE INSTRUMENT'S MAIN TUBE FOUND DURING FAILURE ANALYSIS COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI SI PROSTATECTOMY PROCEDURE, THE BIPOLAR CORD ATTACHMENT ON THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT WAS OBSERVED TO BE MISSING. THERE WERE 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
    1 FENESTRATED BIPOLAR FORCEPSINSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420205-05 M10120420 745

    Patients

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