BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOSCOPE BIOPSY VALVE

    MDR report key: 2993178 · Received February 27, 2013

    Report

    Report Number
    MW5029208
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Date of Event
    January 18, 2013
    Report Date
    January 22, 2013
    Manufacturer
    OLYMPUS AMERICA
    Product Code
    EOQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A COLONOSCOPY PROCEDURE WAS PERFORMED BY THE PHYSICIAN IN THE ICU SETTING. PT NOTED TO HAVE DIVERTICULAR BLEED AT 55 CM IN THE TRANSVERSE COLON. THREE RESOLUTION CLIPS WERE PLACED ON THE BLEEDING DIVERTICULI. THE ASSISTING NURSE NOTED IT WAS DIFFICULT TO PUT DOWN THE BIOPSY CHANNEL ON THE SECOND CLIP. ON THE THIRD CLIP, A SMALL BLACK FRAGMENT CAME OUT OF THE SCOPE AT THE INSERTION POINT. THE PROCEDURE WAS COMPLETED W/O INCIDENT AND THE SMALL BLACK FRAGMENT WAS RETRIEVED THROUGH THE SCOPE. THE NURSE WAS ABLE TO DO PRE-CLEANING AT BEDSIDE AND COLLECTED THE FRAGMENT. THE ITEM WAS SEQUESTERED AND SPS WAS NOTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83424 ENDOSCOPE BIOPSY VALVE BIOPSY CAP (SEMI-REUSABLE) EOQ OLYMPUS AMERICA MB-358

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR