BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LARGE SUTURECUT NEEDLEDRIVERINSTRUMENT

    MDR report key: 3070924 · Received April 22, 2013

    Report

    Report Number
    2955842-2013-01341
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Date of Event
    March 25, 2013
    Report Date
    March 25, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. ENGINEERING NOTED A FRAYED CABLE AT THE DISTAL IDLER PULLEY. THE FRAYED CABLE SECTION WAS APPROXIMATELY 0.04 IN LENGTH. NO DAMAGE WAS FOUND ON THE PULLEY. ONE GRIP CLOSE CABLE WAS DERAILED AT THE DISTAL IDLER PULLEY. THE GRIPS WERE STILL ABLE TO OPEN AND CLOSE BUT THE MOVEMENT MAY NOT BE PRECISE. NO DAMAGE WAS FOUND ON THE DISTAL IDLER PULLEY. 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

    DURING CENTRAL PROCESSING, THE USER FACILITY IDENTIFIED A BROKEN CABLE ON THE LARGE SUTURECUT NEEDLE DRIVER INSTRUMENT . NO MISSING OR FALLEN PIECES WERE REPORTED. THE INSTRUMENT REPORTEDLY WAS NOT USED ON A PATIENT AFTER THE REPORTED ISSUE WAS IDENTIFIED AND THERE WAS NO ALLEGATION OF HARM OR INJURY TO A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171901 LARGE SUTURECUT NEEDLEDRIVERINSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420296-02 M10121203 902

    Patients

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