BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CBX1

    MDR report key: 1760728 · Received July 13, 2010

    Report

    Report Number
    MW5016728
    Event Type
    Malfunction
    Date Received
    July 13, 2010
    Date of Event
    July 2, 2010
    Report Date
    July 13, 2010
    Manufacturer
    KIMBERLY CLARK HEALTH CARE
    Product Code
    KOG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    WHILE DOING A COLONOSCOPY, THE PHYSICIAN WANTED TO DO A BIOPSY. AS HE PASSED THE FORCEPS THROUGH THE CHANNEL, HE PUSHED OUT A SIX INCH LONG PIECE OF A CLEANING BRUSH. BRUSH WAS REMOVED ATRAUMATICALLY. THE FACILITY HAS NOT USED THAT BRAND OF BRUSH SINCE AROUND (B)(6) 2010. THIS SCOPE WAS USED REPEATEDLY FROM (B)(6) 2010 UNTIL (B)(6) 2010. WE DO NOT KNOW HOW LONG THE PIECE OF CLEANING BRUSH WAS IN THE SCOPE. FREQUENCY: ONCE. DATES OF USE: (B)(6) 2008 - (B)(6) 2008. DIAGNOSIS OR REASON FOR USE: CLEANING BIOPSY CHANNEL OF ENDOSCOPE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CBX1 CLEANING DEVICE FOR ENDOSCOPES KOG KIMBERLY CLARK HEALTH CARE CBX1 UNKNOWN
    2 OLYMPUS SCOPE OLYMPUS SCOPE FDF KIMBERLY CLARK HEALTH CARE CF-H180AL

    Patients

    Seq Age Sex Outcome Treatment
    1