BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISPOSABLE ENDOSCOPIC CLEANING BRUSH

    MDR report key: 2460859 · Received February 13, 2012

    Report

    Report Number
    3001845648-2012-00006
    Event Type
    Malfunction
    Date Received
    February 13, 2012
    Date of Event
    January 17, 2012
    Report Date
    January 17, 2012
    Manufacturer
    COOK IRELAND LTD
    Product Code
    MNL
    PMA / PMN Number
    CLASS I NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL NUMBER OF THE DEVICE INVOLVED IN THIS COMPLAINT WAS NOT PROVIDED; THEREFORE, IT WAS NOT POSSIBLE IF THERE WERE ANY DEVICES FROM THE AFFECTED LOT NUMBER IN STOCK AT THE TIME OF THE COMPLAINT INVESTIGATION. A DOCUMENT BASED INVESTIGATION WAS CARRIED OUT AS THE BRUSHES WERE NOT RETURNED FOR EVAL. THE BRUSHES BROKE DURING CLEANING OF THE ENDOSCOPE. IT IS POSSIBLE THAT EXCESS FORCE MAY HAVE BEEN APPLIED. HOWEVER, THIS CANNOT BE CONCLUSIVELY DETERMINED AS WE WERE UNABLE TO REPLICATE THE CONDITIONS OF USE IN THE LAB. PRIOR TO DISTRIBUTION, ALL DCB-DV-50 BRUSHES ARE SUBJECTED TO INSPECTION 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. 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. NO CORRECTIVE ACTION IS WARRANTED AT THIS TIME THERE WAS NO PT CONTACT AND THE TWO YEAR COMPLAINT HISTORY HAS BEEN REVIEWED INDICATING THAT THIS TYPE OF EVENT IS RARE.

    Description of Event or Problem · 1

    THE VALVE BRUSH 10 MM END WAS PUT IN THE SUCTION PORT TO CLEAN THE SCOPE AND THE TIP BROKE. THE TIP BROKE WHERE THE BRISTLES END AND THE HANDLE STARTS. A FORCEP SUCTION WAS USED TO REMOVE THE BRUSH. THIS OCCURRED ON TWO BRUSHES. THE PRODUCT LOT NUMBER IS UNK. A PENTAX 155 SCOPE WAS BEING CLEANED FOR EACH BRUSH. THE DETERGENT THAT WAS BEING USED WAS INTERCEPT DETERGENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA