BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PK DISSECTING FORCEPS INSTRUMENT

    MDR report key: 3011941 · Received March 20, 2013

    Report

    Report Number
    2955842-2013-00910
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Date of Event
    February 20, 2013
    Report Date
    February 20, 2013
    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

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT ENGINEERING EVALUATION FOUND THAT THE NONCONFORMANCE WAS A BROKEN CONDUCTOR WIRE. THE ONE CONDUCTOR WIRE WAS BROKEN AT THE YAW PULLEY EXIT. THE WIRE WAS DETACHED FROM ITS CONNECTION AT THE GRIP. THE ELECTRICAL CONTINUITY TESTING FAILED. THE YAW PULLEY WAS MISSING A PIECE AT THE SAME AREA OF THE CONDUCTOR BREAK, ALLOWING THE GRIP TO MOVE WITHIN THE PULLEY AND HAVE A LARGER RANGE OF MOTION IN THE YAW. IT WAS UNCLEAR HOW THE YAW PULLEY BROKE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO STARTING A DA VINCI SI SURGICAL PROCEDURE, THE PK DISSECTING FORCEPS INSTRUMENT WAS NOTED TO HAVE A BROKEN WIRE AT THE DISTAL END. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115031 PK DISSECTING FORCEPS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420227-03 M10090501 841

    Patients

    Seq Age Sex Outcome Treatment
    1 DAVINCI SI SYSTEM, ESU, INSTRUMENTS & ACCESSORIES