BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISPOSABLE ENDOSCOPIC CLEANING BRUSH SET

    MDR report key: 1062449 · Received June 18, 2008

    Report

    Report Number
    3001845648-2008-00002
    Event Type
    Injury
    Date Received
    June 18, 2008
    Date of Event
    May 22, 2008
    Report Date
    May 23, 2008
    Manufacturer
    COOK IRELAND LTD
    Product Code
    MNL
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL: AS THE CLEANING BRUSH INVOLVED IN THE REPORT WAS NOT RETURNED FOR EVAL; THE REPORTED OCCURRENCE COULD NOT BE CONFIRMED. A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE CARRIED OUT AS THE LOT NUMBER OF THE CLEANING BRUSH INVOLVED IN THE REPORT IS UNK. AFTER A REVIEW OF THE ACCOUNT ORDER HISTORY, THE LOT NUMBER OF THE CLEANING BRUSH COULD NOT BE DETERMINED. A REVIEW OF THE 2-YEAR COMPLAINT HISTORY FOR THIS PRODUCT FAMILY WAS CONDUCTED. THIS TYPE OF REPORT REPRESENTS AN UNUSUAL OCCURRENCE. CONCLUSION: THE FULL INVESTIGATION COULD NOT BE PERFORMED BECAUSE THE CLEANING BRUSH WAS NOT RETURNED FOR EVAL. THE CAUSE OF THE REPORT COULD NOT BE CONCLUSIVELY DETERMINED. HOWEVER WE CAN PROVIDE THE FOLLOWING COMMENTS: THE DISPOSABLE ENDOSCOPIC CLEANING BRUSH IS USED FOR CLEANING THE ACCESSORY CHANNELS OF ENDOSCOPES BETWEEN USES AND THE CLEANING BRUSH IS NOT MEDICAL DEVICE USED ON A PT. THE CLEANING BRUSH IS SUPPLIED NON-STERILE AND IS DISPOSABLE - INTENDED FOR SINGLE USE ONLY. THE MAKE AND MODEL OF THE ENDOSCOPE THAT THE DCB-DV-50 CLEANING BRUSH WAS BEING USED TO CLEAN IS UNK AT THIS TIME, THEREFORE WE CANNOT DETERMINE IF THE CLEANING BRUSH IS COMPATIBLE WITH THE ENDOSCOPE. IF THE CLEANING BRUSH WAS USED TO CLEAN AN ENDOSCOPE THAT IS NOT COMPATIBLE WITH THE CLEANING BRUSH, THIS COULD HAVE CREATED RESISTANCE DURING THE CLEANING PROCESS. IF EXCESSIVE PRESSURE WAS APPLIED TO THE CLEANING BRUSH, PERHAPS IN RESPONSE TO RESISTANCE, THIS COULD HAVE CONTRIBUTED TO BRUSH DETACHMENT INSIDE THE ACCESSORY CHANNEL OF THE ENDOSCOPE. PRIOR TO DISTRIBUTION, ALL DISPOSABLE ENDOSCOPIC CLEANING BRUSHES ARE SUBJECTED TO VISUAL INSPECTION TO ENSURE DEVICE INTEGRITY. CORRECTIVE ACTION: NO CORRECTIVE ACTION IS WARRANTED AT THIS TIME BECAUSE THIS REPORT WAS UNABLE TO BE VERIFIED. THIS OBSERVATION REPRESENTS AN UNUSUAL OCCURRENCE. CUSTOMER QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS.

    Description of Event or Problem · 1

    THE BRUSH HEAD OF THE DISPOSABLE CLEANING BRUSH BROKEN OFF FROM THE CATHETER INSIDE AN ENDOSCOPE. THIS WAS NOT NOTICED BY THE HOSPITAL STAFF CLEANING THE ENDOSCOPE AND THE BRUSH HEAD WAS LEFT IN THE ENDOSCOPE. AFTER THIS THE ENDOSCOPE WENT THROUGH FURTHER CLEANING PROCEDURES, THE ENDOSCOPE WAS THEN USED FOR A PROCEDURE ON A PT. THIS RESULTED IN THE BRUSH HEAD BEING PUSHED OUT OF THE ENDOSCOPE AND INTO THE PT. THE BRUSH HEAD WAS RETRIEVED FROM THE PT. THERE WERE NO ADVERSE EFFECTS ON THE PT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention