BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEANFREAK DUAL ENDED ENDOSCOPE CLEANING BRUSH

    MDR report key: 9481826 · Received December 17, 2019

    Report

    Report Number
    2183446-2019-00003
    Event Type
    Malfunction
    Date Received
    December 17, 2019
    Date of Event
    November 13, 2019
    Report Date
    November 21, 2019
    Manufacturer
    DIVERSATEK HEALTHCARE
    Product Code
    MNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER DID NOT DIRECTLY NOTIFY DEVICE MANUFACTURER. DEVICE MANUFACTURER RECEIVED A COPY OF MEDWATCH REPORT MW5091319 VIA THE MAIL ON 12-16-2019. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO ANOMALIES WITH THE TUBING COMPONENT LOT OR THE PRODUCTION LOT WAS NOTED FOR THIS DEVICE LOT THAT WOULD HAVE CONTRIBUTED TO THIS FAILURE. THE PRODUCT PROBLEM RATE FOR THIS DEVICE FAMILY IS WITHIN HISTORICAL LEVELS. NO OTHER COMPLAINTS WERE RECEIVED ON THIS PRODUCTION LOT AS OF THIS REPORT. THIS IS A KNOWN ISSUE WITH NOT ONLY THE DIVERSATEK HEALTHCARE DESIGN BUT WITH OTHER COMPETITOR PRODUCTS AS WELL. THE TUBE DESIGN OF AN ENDOSCOPE CLEANING BRUSH MUST BE SMALL AND FLEXIBLE TO NAVIGATE THE WORKING CHANNEL OF THE ENDOSCOPE. THE TUBE IS DESIGNED TO BE AS STRONG AS POSSIBLE WITHIN THOSE CONSTRAINTS. HOWEVER, WITH EXCESS FORCE AND BENDING, THE TUBE MAY BREAK IN THIS AREA. THIS CLEANING BRUSH HAS NO PATIENT CONTACT. THIS INHERENT DEVICE RISK HAS NO PATIENT RISK UNLESS OTHER FAILURES ARE PRESENT IN ENDOSCOPE REPROCESSING. DIVERSATEK HEALTHCARE HAS DETERMINED THAT THERE ARE NO NEW SAFETY OR EFFICACY ISSUES AS A RESULT OF THIS EVENT AND THEREFORE, NO FURTHER ACTION WILL BE TAKEN.

    Description of Event or Problem · 1

    EVENT DESCRIPTION FROM MW5091319. WHEN CLEANING A COLONOSCOPE (LOT 001892), A SECTION OF THE BRUSH BROKE OFF. BROKEN COMPONENT DID NOT COME OUT "INITIALLY", BUT AFTER NUMEROUS TIMES IT DID. THE SECTION IS ABOUT 12" LONG. SCOPE SENT TO MFR TO VERIFY ("MU" HAS BEEN REMOVED AND NO DAMAGE TO THE SCOPE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1280131 CLEANFREAK DUAL ENDED ENDOSCOPE CLEANING BRUSH ACCESSORIES, CLEANING BRUSHES FOR ENDOSCOPES MNL DIVERSATEK HEALTHCARE 1200-04 001892

    Patients

    Seq Age Sex Outcome Treatment
    1