BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PK DISSECTING FORCEPS INSTRUMENT

    MDR report key: 3915658 · Received July 7, 2014

    Report

    Report Number
    2955842-2014-04108
    Event Type
    Malfunction
    Date Received
    July 7, 2014
    Date of Event
    June 9, 2014
    Report Date
    June 9, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K061260
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED INVESTIGATIONS. FAILURE ANALYSIS INVESTIGATIONS CONFIRMED THE INITIAL REPORTER'S COMPLAINT. ONE CONDUCTOR WIRE WAS BROKEN AT THE YAW PULLEY EXIT. THE WIRE WAS DETACHED FROM ITS CONNECTION AT THE GRIP. THE ELECTRICAL CONTINUITY TEST FAILED. THE YAW PULLEY SHOWED NO SIGNS OF ARCING. AN ADDITIONAL OBSERVATION NOT REPORTED BY THE SITE WAS THAT THE INSTRUMENT MAIN TUBE HAD SCRATCH MARKS/ABRASIONS. THE DISTAL END OF THE MAIN TUBE HAD VARIOUS SCRATCH MARKS WITH LIGHT MATERIAL REMOVAL. THE SCRATCHES WERE NOT ALIGNED WITH THE TUBE AXIS. AN ADDITIONAL OBSERVATION NOT REPORTED BY THE SITE WAS THAT THE INSTRUMENT BIPOLAR YAW PULLEY WAS BROKEN. THE YAW PULLEY WAS MISSING A PIECE, WHICH ALLOWED THE GRIP TO MOVE WITHIN THE PULLEY AND HAVE LARGER RANGE OF MOTION IN THE YAW. ADDED RANGE OF MOTION IN THE GRIP LIKELY CREATED EXCESS TENSION ON THE WIRE, CAUSING IT TO BREAK. FAILURE ANALYSIS CONCLUDED THAT THE BROKEN DAMAGE MAY BE DUE TO MISHANDLING/ MISUSE. 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. ISI HAS ATTEMPTED TO CONTACT THE SITE SEVERAL TIMES TO OBTAIN ADDITIONAL INFORMATION CONCERNING THE REPORTED EVENT; HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AS OF THE DATE OF THIS REPORT. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER; THE MALFUNCTION OF THE MAIN TUBE AND BROKEN YAW PULLEY 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 HYSTERECTOMY PROCEDURE, THE SURGICAL STAFF NOTICED THAT THE CABLE WAS BROKEN ON THE PK DISSECTING FORCEPS INSTRUMENT. IT WAS NOTED THAT UPON RETRACTION INTO THE CANNULA, THE INSTRUMENT GOT STUCK AT THE TIP. THE PLASTIC CERAMIC HOUSING BROKE AND PREVENTED THE INSTRUMENT FROM BEING REMOVED. THERE WERE NO MISSING OR FALLEN PIECES REPORTED. THERE WAS NO ALLEGATION OF ANY HARM, INJURY, OR ADVERSE OUTCOME TO A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    393866 PK DISSECTING FORCEPS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420227-03 M10110809 202

    Patients

    Seq Age Sex Outcome Treatment
    1