BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WOOLY BRUSH

    MDR report key: 2043474 · Received February 25, 2011

    Report

    Report Number
    1528319-2011-00003
    Event Type
    Malfunction
    Date Received
    February 25, 2011
    Date of Event
    January 26, 2011
    Report Date
    February 25, 2011
    Manufacturer
    UNITED STATES ENDOSCOPY GROUP, INC.
    Product Code
    MNL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO MFR SO THE ROOT CAUSE OF THIS INCIDENT HAS NOT BEEN DEFINITIVELY DETERMINED. ANALYSIS OF COMPLAINT TRENDING INFO WAS PERFORMED AND NO SIMILAR COMPLAINTS FROM THE LOT CONCERNED HAVE BEEN FILED.

    Description of Event or Problem · 1

    THE CLEANING BRUSH WAS USED TO CLEAN A SCOPE. THE BRUSH HEAD REPORTEDLY BROKE OFF INSIDE THE SCOPE. THE SCOPE WAS THEN REPROCESSED. DURING A ROUTINE COLONOSCOPY PROCEDURE CUSTOMER NOTICED THAT THE SUCTION PORTION OF THE SCOPE WAS NOT FUNCTIONING PROPERLY. THE CUSTOMER USED A 60CC SYRINGE OF WATER TO FLUSH THE BIOPSY CHANNEL AND WHEN FLUSHED A CLEANING BRUSH HEAD CAME OUT INTO THE PT. THE BRUSH HEAD WAS IMMEDIATELY RETRIEVED USING A FORCEP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WOOLY BRUSH CLEANING BRUSH MNL UNITED STATES ENDOSCOPY GROUP, INC. 00711612 29113

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention