BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE USE ASPIRATION NEEDLE

    MDR report key: 3042040 · Received April 5, 2013

    Report

    Report Number
    3042040
    Event Type
    Malfunction
    Date Received
    April 5, 2013
    Date of Event
    March 31, 2013
    Report Date
    April 5, 2013
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FCG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AS RN WAS PREPARING CASE SHE NOTICED THAT THE NEEDLE WAS BENT. DEVICE NOT USED.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?ENDOSCOPIC PROCEDURE.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    140063 SINGLE USE ASPIRATION NEEDLE KIT, NEEDLE, BIOPSY FCG OLYMPUS MEDICAL SYSTEMS CORP. NA-201SX-4021 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *