BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA

    MDR report key: 3042122 · Received April 3, 2013

    Report

    Report Number
    3042122
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    March 20, 2013
    Report Date
    April 3, 2013
    Manufacturer
    OLYMPUS CORPORATION OF THE AMERICAS
    Product Code
    EOQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US

    Narratives

    Description of Event or Problem · 1

    DURING A BRONCHOSCOPY, A PLASTIC RING FROM THE TIP OF THE ENDOSCOPE BROKE OFF IN THE PATIENT. THE PHYSICIAN RETRIEVED THE PLASTIC RING MATERIAL AND THE RING BROKE INTO TWO PIECES AFTER REMOVAL FROM THE PATIENT. A VISUAL INSPECTION WAS MADE OF THE AREA AND THERE WAS NO OTHER FOREIGN BODY SEEN. THERE WAS NO HARM TO THE PATIENT. A VISUAL INSPECTION OF ALL OLYMPUS ENDOSCOPES WAS PERFORMED BY THE OLYMPUS REPRESENTATIVE ABOUT ONE MONTH PRIOR TO THIS EVENT.======================MANUFACTURER RESPONSE FOR SCOPE BF-IT160, BRONCHOSCOPE (PER SITE REPORTER).======================FIELD OLYMPUS REPRESENTATIVE TOOK THE BROKEN RING FOR EVALUATION.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?BRONCHOSCOPY.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135959 EVIS EXERA BRONCHOSCOPE EOQ OLYMPUS CORPORATION OF THE AMERICAS BF TYPE 1T160 *

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR NO