BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEAN FREAK COMBINATION ENDOSCOPE CLEANING BRUSH

    MDR report key: 6427396 · Received March 20, 2017

    Report

    Report Number
    MW5068599
    Event Type
    Malfunction
    Date Received
    March 20, 2017
    Date of Event
    March 17, 2017
    Report Date
    March 20, 2017
    Manufacturer
    MEDOVATIONS INC.
    Product Code
    MNL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ENDOSCOPIC CLEANING BRUSH TIP HAD BROKEN OFF AND WAS LEFT IN SCOPE (UNNOTICED) AFTER PREVIOUS WASH. WHEN PHYSICIAN WENT TO INSERT AN INSTRUMENT DURING A PROCEDURE IN TO THE SCOPE, HE WAS UNABLE TO PASS THRU THE OBSTRUCTION. THE SCOPE WAS REPLACED WITH ANOTHER SCOPE, AND THE PROCEDURE WAS COMPLETED WITHOUT ANY COMPLICATIONS TO THE PATIENT OR SCOPE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    199595 CLEAN FREAK COMBINATION ENDOSCOPE CLEANING BRUSH CLEAN FREAK COMBINATION ENDOSCOPE CLEANING BRUSH MNL MEDOVATIONS INC. 000676

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR