BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 1561280 · Received December 7, 2009

    Report

    Report Number
    1561280
    Event Type
    Malfunction
    Date Received
    December 7, 2009
    Date of Event
    November 24, 2009
    Report Date
    December 7, 2009
    Manufacturer
    BK MEDICAL SYSTEMS, INC.
    Product Code
    GCF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE TIP OF THE INTRODUCER AND HANDLE CAME APART AT ENDS WHERE THEY ARE WELDED. NO HARM OCCURRED TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * INTRODUCER FOR RIGID PROCTOSCOPE GCF BK MEDICAL SYSTEMS, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR