BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEGA NEEDLE DRIVER INSTRUMENT

    MDR report key: 3132654 · Received May 29, 2013

    Report

    Report Number
    2955842-2013-01859
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    May 3, 2013
    Report Date
    May 3, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTUITIVE SURGICAL, INC. RECEIVED THE INSTRUMENT INVOLVED WITH THE COMPLAINT. ENGINEERING CONFIRMED THAT THE MAIN TUBE (SHAFT) OF THE INSTRUMENT WAS BROKEN AT THE DISTAL END, ROUGHLY 2.5 ABOVE THE PROXIMAL CLEVIS. THE MAIN TUBE WAS BENT AS A RESULT OF THE MAIN TUBE BREAKAGE AND WILL NOT FIT SMOOTHLY THROUGH A CANNULA. ENGINEERING CONCLUDED THAT THE MAIN TUBE DAMAGE MAY BE DUE TO MISHANDLING. NO OTHER DAMAGE WAS FOUND. THE INSTRUMENTS & ACCESSORIES 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

    PRIOR TO STARTING A DA VINCI SI SURGICAL PROCEDURE, THE USER FACILITY IDENTIFIED A BROKEN SHAFT ON THE MEGA 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
    234645 MEGA NEEDLE DRIVER INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420194-08 M10121212 261

    Patients

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