BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PK DISSECTING FORCEPS INSTRUMENT

    MDR report key: 3211996 · Received July 8, 2013

    Report

    Report Number
    2955842-2013-02469
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    May 30, 2013
    Report Date
    June 10, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K061260
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. ENGINEERING CONFIRMED THE REPORTED COMPLAINT WITH THE FOLLOWING CLARIFICATION, THE CONDUCTOR WIRE WAS BROKEN. THE DRIVE CABLES WERE INTACT AT THE DISTAL END, HOWEVER; ONE CONDUCTOR WIRE WAS BROKEN AT THE YAW PULLEY EXIT. THE WIRE WAS DETACHED FROM ITS CONNECTION AT THE GRIP. ELECTRICAL CONTINUITY FAILED. THE YAW PULLEY SHOWED NO SIGNS OF ARCING. ADDITIONAL OBSERVATION NOT REPORTED BY THE SITE WAS A BROKEN YAW PULLEY. THE YAW PULLEY WAS MISSING A .225 X .060 PIECE ON THE SAME SIDE AS THE CONDUCTOR BREAK. NO OTHER DAMAGE WAS FOUND. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER; THE MISSING PIECE OF YAW PULLEY , FOUND DURING FAILURE ANALYSIS EVALUATION COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF THE FAILURE MODE WERE TO RECUR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO STATING A DA VINCI SI SURGICAL PROCEDURE A PK DISSECTING FORCEPS INSTRUMENT HAD A BROKEN CABLE. 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
    311575 PK DISSECTING FORCEPS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420227-03 M10120924 225

    Patients

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