BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XPS

    MDR report key: 3082129 · Received April 19, 2013

    Report

    Report Number
    3082129
    Event Type
    Malfunction
    Date Received
    April 19, 2013
    Date of Event
    April 12, 2013
    Report Date
    April 19, 2013
    Manufacturer
    MEDTRONIC XOMED, INC.
    Product Code
    EQJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHILE SURGEON WAS USING THE TURBINATE BLADE IN PATIENT'S NARES, THE BLADE BENT AT AN ANGLE, AND REMAIND BENT. REMOVED FROM THE FIELD - NO INJURY TO THE PATIENT.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?ENDOSCOPIC SINUS SURGERY.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171045 XPS BUR, EAR, NOSE AND THROAT EQJ MEDTRONIC XOMED, INC. * H8323525

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR