BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS AMERICA

    MDR report key: 1852893 · Received September 30, 2010

    Report

    Report Number
    MW5017628
    Event Type
    Malfunction
    Date Received
    September 30, 2010
    Report Date
    September 28, 2010
    Manufacturer
    OLYMPUS AMERICA
    Product Code
    KNW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WE HAVE BEEN USING A SINGLE USE BIOPSY VALVE ON OUR COLONOSCOPES AND THE INSIDE OF THE RUBBER DISPOSABLE VALVE IS COMING OUT IN THE SCOPE DURING THE PROCEDURE. TO DATE, WE HAVE BEEN ABLE TO RETRIEVE EACH RUBBER PIECE FROM THE SCOPE OR SEND THE SCOPE OUT FOR THE PIECE TO BE RETRIEVED. THE FACILITY IS NOT USING DUE TO MAJOR SAFETY ISSUES WITH THE ITEM BEING LEFT INSIDE A PT AND NOT KNOWING IT. THIS IS A DISPOSAL ITEM AND THE FOREIGN BODY LEFT IN A PT IS TOO STRONG TO CONTINUE USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS AMERICA SINGLE USE BIOPSY VALVE KNW OLYMPUS AMERICA MAJ -1555 ALL SO FAR

    Patients

    Seq Age Sex Outcome Treatment
    1 Other