BEUDAMED
    FDA Adverse Event Other Summary report: N

    WOOLY BRUSH CHANNEL BRUSH

    MDR report key: 2851106 · Received November 15, 2012

    Report

    Report Number
    1528319-2012-00022
    Event Type
    Other
    Date Received
    November 15, 2012
    Date of Event
    September 2, 2011
    Report Date
    November 14, 2012
    Manufacturer
    UNITED STATES ENDOSCOPY GROUP, INC.
    Product Code
    MNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED EVENT WAS DISCARDED AND COULD NOT BE EVALUATED. CLEANING BRUSHES ARE INTENDED TO CLEAN THE INTERIOR LUMENS AND OPENINGS OF A SCOPE TO REMOVE ANY TISSUE, BLOOD OR OTHER DEBRIS REMAINING IN THE SCOPE AFTER USE. FOLLOWING MANUAL CLEANING, THE SCOPE IS TO BE FURTHER CLEANED IN ENZYMATIC CLEANER AND TERMINALLY PROCESSED TO ENSURE THE DEVICE LUMENS ARE CLEAR OF ANY OBSTRUCTIONS. THE USER CLEANING THE ENDOSCOPE SUBJECT OF THIS REPORTED EVENT DID NOT RECOGNIZE THAT A PIECE OF THE BRUSH WAS MISSING AND SUBSEQUENTLY DID NOT TAKE STEPS TO REMOVE THE BROKEN PIECES OF THE CLEANING BRUSH. IT IS IMPORTANT IN THE USE OF CLEANING BRUSHES THAT USERS NOT FORCE THE CLEANING BRUSH THROUGH THE ENDOSCOPE SHOULD THE CHANNELS BE OCCLUDED OR RESISTANCE IS MET.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT A CLEANING BRUSH HEAD DETACHED DURING MANUAL CLEANING OF AN ENDOSCOPE AND WENT UNDETECTED BY THE USER UNTIL THE PHYSICIAN BEGAN A PATIENT PROCEDURE TO REMOVE A FOOD IMPACTION. THE PHYSICIAN NOTED ONLY THE TIP OF CLEANING BRUSH PROTRUDING FROM THE ENDOSCOPE; THE BRUSH HEAD REMAINED LODGED IN THE SCOPE. THE PHYSICIAN REMOVED THE SCOPE AND COMPLETED THE PROCEDURE SUCCESSFULLY WITH ANOTHER SCOPE; NO PATIENT OR USER INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WOOLY BRUSH CHANNEL BRUSH MNL UNITED STATES ENDOSCOPY GROUP, INC. EA00711612

    Patients

    Seq Age Sex Outcome Treatment
    1