BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEGASUTURECUT NEEDLE DRIVER INSTRUMENT

    MDR report key: 3210881 · Received July 8, 2013

    Report

    Report Number
    2955842-2013-02457
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    May 20, 2013
    Report Date
    June 11, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING OBSERVED THAT THE INSTRUMENT'S GRIP DIDN'T MOVE SMOOTHLY WHEN MANUALLY ROTATED. VISUAL INSPECTION SHOWED CORRODED WITH DRY BIO RESIDUE AROUND THE TIP BLADE AREA. ENGINEERING CONCLUDED THAT CORRODED DAMAGE WAS LIKELY DUE TO NOT PROPERLY CLEANING THE INSTRUMENT. ADDITIONAL OBSERVATIONS NOT REPORTED BY SITE WERE PULLEY DAMAGE AND MAIN TUBE DAMAGE. ENGINEERING OBSERVED INDENTATIONS AT THE EDGE OF THE DISTAL PULLEY. IN ADDITION, THE DISTAL END OF THE MAIN TUBE EXHIBITED VARIOUS SCRATCH MARKS WITH LIGHT MATERIAL REMOVAL. THE SCRATCHES WERE SHORT IN LENGTH AND WERE NOT ALIGNED WITH THE TUBE AXIS. ENGINEERING CONCLUDED THAT MAIN TUBE 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 MAIN TUBE SCRATCHES 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 S HYSTERECTOMY PROCEDURE, THE CUSTOMER NOTED THAT THE MEGA SUTURE CUT NEEDLE DRIVER INSTRUMENT WAS STIFF. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311748 MEGASUTURECUT NEEDLE DRIVER INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420309-01 M10121219 622

    Patients

    Seq Age Sex Outcome Treatment
    1 DA VINCI S SYSTEM INSTRUMENTS AND ACCESSORIES