BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAINBOW ENDOSCOPIC CLEANING BRUSH

    MDR report key: 3908287 · Received May 28, 2014

    Report

    Report Number
    3001845648-2014-00090
    Event Type
    Malfunction
    Date Received
    May 28, 2014
    Date of Event
    April 22, 2014
    Report Date
    April 29, 2014
    Manufacturer
    COOK IRELAND LTD
    Product Code
    MNL
    PMA / PMN Number
    CLASS I N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    UNKNOWN

    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 BREAKAGE'; REGARDLESS OF PATIENT OUTCOME. THERE WAS NO RCB-220-S DEVICE OF LOT CF890206 IN STOCK AT THE TIME OF THE INVESTIGATION. ONE X RCB-220-S DEVICE OF LOT# CF890206 WAS RETURNED FOR EVALUATION. IT WAS RETURNED IN ITS ORIGINAL PACKAGING AND WAS OPEN ON RECEIPT. UPON EVALUATION IT WAS NOTED THAT BOTH ENDS OF THE RETURNED DEVICE WERE BROKEN. ONLY THE COILED WIRE WAS RETURNED. THE BROKEN HANDLE AND BRUSH PARTS OF THE BROKEN DEVICE WERE NOT RETURNED FOR EVALUATION. THE CIRL MANUFACTURING ENGINEER COMMENTED DURING THE EVALUATION THAT UPON EXAMINATION OF THE RETURNED BROKEN DEVICE IT LOOKED LIKE FORCE MAY HAVE BEEN APPLIED WHEN USING THE DEVICE. THE CUSTOMER COMPLAINT WAS CONFIRMED AS BOTH ENDS OF THE RETURNED DEVICE WERE BROKEN. A POSSIBLE CAUSE OF THIS COMPLAINT COULD BE IF EXCESSIVE PRESSURE WAS APPLIED TO THE CLEANING BRUSH WHEN CLEANING THE GASTROINTESTINAL ENDOSCOPES BUT AS WE CANNOT REPLICATE CONDITIONS OF USE IN THE LABORATORY WE CANNOT CONCLUSIVELY DETERMINE THE ROOT CAUSE OF THIS COMPLAINT. IT MAY BE NOTED THAT RCB DEVICES ARE USED TO CLEAN UPPER AND LOWER GASTROINTESTINAL ENDOSCOPES AND HAVE NO PATIENT CONTACT. THE DEVICE IS REUSABLE IF ITS INTEGRITY REMAINS INTACT. AS PER THE INFORMATION PROVIDED, THE ISSUE OCCURRED WHEN THE BRUSH WAS USED FOR A SECOND TIME. ACCORDING TO THE INSTRUCTIONS FOR USE, THE USER IS INSTRUCTED TO DO THE FOLLOWING: "BEFORE AND AFTER USE, VISUALLY INSPECT THE DEVICE. IF THE DEVICE IS DAMAGED OR THE BRISTLES ARE WORN, DO NOT CONTINUE TO USE, AS THIS MAY RESULT IN DAMAGE TO THE ENDOSCOPE. NEVER FORCE THE BRUSH IF THERE IS EXCESSIVE RESISTANCE DURING USE" PRIOR TO DISTRIBUTION ALL RAINBOW ENDOSCOPIC CLEANING BRUSH SETS ARE SUBJECT TO VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE MANUFACTURING RECORDS FOR RCB-220-S (CF890206) REVEALED NO DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT. QUALITY ENGINEERING ASSESSED THE COMPLAINT AND THE OVERALL RISK HAS BEEN DETERMINED TO BE LOW. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS

    Description of Event or Problem · 1

    BRUSH WAS STERILIZED BY EO AND WAS USED FOR A SECOND TIME. THE BRUSH BECAME DISCONNECTED FROM THE HANDLE AND DROPPED INSIDE THE ENDOSCOPE. THE BRUSH WAS SUCCESSFULLY RETRIEVED FROM THE ENDOSCOPE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314877 RAINBOW ENDOSCOPIC CLEANING BRUSH MNL ACCESSORIES, CLEANING BRUSHES, FOR ENDOSCOPES MNL COOK IRELAND LTD CF890206

    Patients

    Seq Age Sex Outcome Treatment
    1 NA