BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DOUBLE-HEADER

    MDR report key: 1844289 · Received September 3, 2010

    Report

    Report Number
    1844289
    Event Type
    Malfunction
    Date Received
    September 3, 2010
    Date of Event
    August 25, 2010
    Report Date
    September 2, 2010
    Manufacturer
    US ENDOSCOPY
    Product Code
    FEB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US

    Narratives

    Description of Event or Problem · 1

    DURING CLEANING OF THE COLONSCOPE, IT WAS NOTICED THAT THE TIP OF THE CLEANING BRUSH HAD BROKEN OFF. THE TECHNICIAN SEARCHED FOR THE TIP, BUT COULD NOT FIND IT. FOLLOWING CLEANING OF THE SCOPE, THE SCOPE WAS X-RAYED AND THE BRUSH TIP WAS NOT SEEN. IT WAS THOUGHT THAT THE BRUSH TIP HAD FALLEN INTO THE SINK AND GONE DOWN THE DRAIN.THE SCOPE WAS WASHED IN A SCOPE WASHER, FLUSHED WITH ALCOHOL, AND HUNG TO DRY.DURING A COLONSCOPY PROCEDURE, THE BRUSH TIP FELL OUT OF THE SCOPE INTO THE PATIENT. THE PHYSICIAN WAS ABLE TO RETRIEVE THE BRUSH TIP.DEVICE #1IS DEVICE INVOLVED IN HIT ISSUENO

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DOUBLE-HEADER ENDOSCOPE CLEANING BRUSH FEB US ENDOSCOPY * 32675
    2 EVIS EXERA COLONOSCOPE FDF OLYMPUS PCF-160AL *

    Patients

    Seq Age Sex Outcome Treatment
    1 *