BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CB - X II DUAL - ENDED CLEANING BRUSH

    MDR report key: 1210884 · Received October 24, 2008

    Report

    Report Number
    MW5008733
    Event Type
    Malfunction
    Date Received
    October 24, 2008
    Date of Event
    October 2, 2008
    Report Date
    October 9, 2008
    Manufacturer
    KIMBERLY CLARK GLOBAL SALES, INC.
    Product Code
    KNW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    AT THE BEGINNING OF COLONOSCOPY, A BIOPSY FORCEP WAS INTRODUCED THROUGH THE BIOPSY CHANNEL. TIP OF SCOPE CLEANING BRUSH WAS NOTED AT THE DISTAL TIP OF COLONOSCOPE. WHEN BIOPSY FORCEP WAS INTRODUCED THROUGH BIOPSY CHANNEL PRIOR TO TAKING BIOPSY FROM SIGMOID COLON, APPARENTLY PUSHED OUT BY THE BIOPSY FORCEP. COLONOSCOPE WAS REMOVED. TIP OF CLEANING BRUSH WAS RETRIEVED AND PLACED IN A SPECIMEN CONTAINER. NO BIOPSIES WERE TAKEN UP TO THIS POINT. NEW COLONOSCOPE WAS INTRODUCED, BIOPSIES WERE THEN TAKEN AND PROCEDURE WAS COMPLETED WITHOUT INCIDENT. COLONOSCOPE WAS CAREFULLY WITHDRAWN FROM PT WITH NO APPARENT INJURY TO COLONIC MUCOSA. BALLARD MEDICAL PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CB - X II DUAL - ENDED CLEANING BRUSH KNW KIMBERLY CLARK GLOBAL SALES, INC. 60218 M 8168E 302

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other