BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEGASUTURECUT NEEDLE DRIVER INSTRUMENT

    MDR report key: 3180560 · Received June 20, 2013

    Report

    Report Number
    2955842-2013-02236
    Event Type
    Malfunction
    Date Received
    June 20, 2013
    Date of Event
    May 13, 2013
    Report Date
    June 5, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING OBSERVED THAT THE NEEDLE DRIVER INSTRUMENT WAS FOUND WITH INDENTATIONS ON BLADES WHICH PREVENTED THE GRIP TO CLOSE COMPLETELY. THE BLADES WERE FOUND TO BE DAMAGED. NO OTHER DAMAGE WAS FOUND. ENGINEERING CONCLUDED THAT DAMAGE WAS LIKELY DUE TO MISHANDLING. THE ENDOWRIST INSTRUMENTS INSTRUCTIONS FOR USE (IFU) SPECIFICALLY STATES: GENERAL PRECAUTIONS AND WARNINGS HANDLE INSTRUMENTS WITH CARE. AVOID MECHANICAL SHOCK OR STRESS THAT CAN CAUSE DAMAGE TO THE INSTRUMENTS. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A REPORTABLE EVENT; HOWEVER, THE REPORTED MALFUNCTION IF TO REOCCUR COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI SI HYSTERECTOMY PROCEDURE, THE CUSTOMER NOTED THE MEGA SUTURE CUT NEEDLE DRIVER INSTRUMENT WAS NOT HOLDING THE NEEDLE, NO PIECES WERE REPORTED AS FALLEN INTO THE PATIENT. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279548 MEGASUTURECUT NEEDLE DRIVER INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420309-01 M10130122 561

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES