BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DOUBLE HEADER

    MDR report key: 2043500 · Received February 25, 2011

    Report

    Report Number
    1528319-2011-00004
    Event Type
    Malfunction
    Date Received
    February 25, 2011
    Date of Event
    January 27, 2011
    Report Date
    February 25, 2011
    Manufacturer
    UNITED STATES ENDOSCOPY GROUP, INC.
    Product Code
    KOG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS DISCARDED BY THE FACILITY SO THE ROOT CAUSE OF THIS INCIDENT CANNOT BE DEFINITIVELY DETERMINED. ANALYSIS OF COMPLAINT TRENDING INFO WAS PERFORMED AND NO SIMILAR COMPLAINTS FROM THIS LOT CONCERNED HAVE BEEN FILED.

    Description of Event or Problem · 1

    THE CLEANING BRUSH WAS USED TO CLEAN A SCOPE. THE BRUSH HEAD REPORTEDLY BROKE OFF INSIDE THE SCOPE. THE SCOPE WAS THEN REPROCESSED. IN A CASE IN THE IFU, A CLEANING BRUSH WAS PUSHED OUT OF THE SCOPE AND INTO A PT. UNITED STATES ENDOSCOPY HAS TRIED TO GATHER FURTHER DETAILS FROM THE FACILITY BUT THEY HAVE NOT PROVIDED ANY ADDITIONAL INFO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DOUBLE HEADER CLEANING BRUSH KOG UNITED STATES ENDOSCOPY GROUP, INC. 00711609 39853

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention