BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISPOSABLE ENDOSCOPIC CLEANING BRUSH

    MDR report key: 3853243 · Received April 4, 2014

    Report

    Report Number
    3001845648-2014-00062
    Event Type
    Malfunction
    Date Received
    April 4, 2014
    Report Date
    March 6, 2014
    Manufacturer
    COOK IRELAND LTD
    Product Code
    MNL
    PMA / PMN Number
    CLASS I N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT REPORT MEETS THE REPORTING CRITERIA OF AN FDA MDR REPORT BASED ON THE REPORTING PRECEDENCE ESTABLISHED FOR THIS PRODUCT FAMILY FOR BRUSH BREAKAGES; REGARDLESS OF PT OUTCOME. THE COMPLAINT INFO PROVIDED WAS AS FOLLOWS: "THE CLEANING BRUSH BROKE DURING CLEANING OF A GASTROSCOPE." IT MAY BE NOTED THAT THERE WAS NO PT INVOLVED IN THIS COMPLAINT EVENT. THE DEVICE INVOLVED IN THE COMPLAINT WAS NOT RETURNED FOR EVALUATION. WITH THE INFORMATION PROVIDED A DOCUMENT BASED INVESTIGATION WAS CARRIED OUT. THE ACTUAL LOT NUMBER OF THE DEVICE INVOLVED IN THIS COMPLAINT WAS NOT PROVIDED; THEREFORE, IT WAS NOT POSSIBLE TO ESTABLISH IF THERE WERE ANY DEVICES FROM THE AFFECTED LOT NUMBER IN STOCK AT THE TIME OF THE COMPLAINT INVESTIGATION. PRIOR TO DISTRIBUTION, ALL DISPOSABLE ENDOSCOPIC CLEANING BRUSH SETS ARE SUBJECT TO VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. PRIOR TO DISTRIBUTION, ALL DISPOSABLE ENDOSCOPIC CLEANING BRUSH SETS ARE SUBJECT TO VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE MFG RECORDS FOR THE PRODUCT INVOLVED IN THIS COMPLAINT COULD NOT BE PERFORMED AS THE LOT NUMBER WAS NOT PROVIDED. A POSSIBLE CAUSE OF THIS COMPLAINT COULD BE IF EXCESSIVE PRESSURE WAS APPLIED TO THE CLEANING BRUSH WHEN CLEANING THE GASTROSCOPE, BUT AS THE COMPLAINT DEVICE WAS NOT RETURNED AND WE CANNOT REPLICATE CONDITIONS OF USE AND WE CANNOT CONCLUSIVELY DETERMINED THE ROOT CAUSE OF THIS COMPLAINT. THE DISPOSABLE ENDOSCOPIC CLEANING BRUSH IS INTENDED FOR CLEANING THE ACCESSORY CHANNELS OF ENDOSCOPES. THE DEVICE IS SUPPLIED NON STERILE AND IS INTENDED FOR SINGLE USE ONLY. THE CUSTOMER COMPLAINT WAS CONFIRMED BASED ON THE COMPLAINANT TESTIMONY. QUALITY ENGINEERING WILL CONTINUE TO MONITOR COMPLAINTS FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 1

    THE CLEANING BRUSH BROKE DURING CLEANING OF A GASTROSCOPE. AS PER THE COMPLAINT INFO PROVIDED, THERE WAS NO PT INVOLVEMENT WITH THIS COMPLAINT EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204838 DISPOSABLE ENDOSCOPIC CLEANING BRUSH MNL ACCESSORIES, CLEANING BRUSHES, FOR ENDOSCOPES MNL COOK IRELAND LTD UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA