BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOSCOPE BIOPSY VALVE

    MDR report key: 2993177 · Received February 27, 2013

    Report

    Report Number
    MW5029207
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Date of Event
    June 17, 2012
    Report Date
    February 11, 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

    DURING EGD PROCEDURE, THE PHYSICIAN PUSHED A RESOLUTION CLIP DEVICE THROUGH THE BIOPSY VALVE AND WITHDREW THE DEVICE FROM THE SCOPE. THE SCOPE QUICKLY BECAME NON-FUNCTIONAL (UNABLE TO SUCTION). THIS SCOPE WAS EXCHANGED FOR ANOTHER ONE, SO AS TO FINISH THE PROCEDURE. THE ENDOSCOPE WAS CLEANED AFTERWARD AND THE CHANNEL WAS UNCLOGGED BY THE USE OF A CLEANING BRUSH. A ROUND BLACK RUBBER PIECE CAME OUT THROUGH THE DISTAL END OF THE SCOPE. NO PT INJURY OCCURRED, NOR WAS THE SCOPE DAMAGED. ALL REUSABLE BLACK BIOPSY VALVES WERE EXCHANGED WITH NEW ONES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83929 ENDOSCOPE BIOPSY VALVE FLEXIBLE ENDOSCOPE BIOPSY VALVE (SEMI-DISPOSABLE/REUSABLE) EOQ OLYMPUS AMERICA MB-358 *

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR