BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHANNEL-OPENING CLEANING BRUSH

    MDR report key: 10476230 · Received September 1, 2020

    Report

    Report Number
    8010047-2020-06062
    Event Type
    Malfunction
    Date Received
    September 1, 2020
    Date of Event
    August 5, 2020
    Report Date
    September 1, 2020
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    MNL
    UDI-DI
    04953170023187
    PMA / PMN Number
    CLASS1-EXMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE WAS RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION. OMSC CHECKED THE SUBJECT DEVICE AND FOUND FOLLOWING. THE SHAFT HAD BEEN BENT AND STRETCHED. SOME BRISTLES ON THE DISTAL END SIDE HAD BEEN MISSING. SOME BRISTLES HAD BEEN CRUSHED. THERE WAS THE DENT ON THE DISTAL END. OMSC COMPARED THE SUBJECT DEVICE AND THE UNUSED DEVICE, OMSC SURMISED THAT THE SUBJECT DEVICE WAS NOT UNUSED. BASED UPON THE ABOVE, OMSC CONCLUDED THAT THE REPORTED PHENOMENON WAS ATTRIBUTED TO THE APPLYING THE EXTERNAL FORCE SUCH AS THE HIT AGAINST SOMETHING OR SCRATCH DUE TO THE HANDLING BY THE USER. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED THAT DURING THE REPROCESS, THE USER OPENED THE PACKAGE OF THE SUBJECT DEVICE, THE USER SEEMED THAT THE BRISTLES OF THE SUBJECT DEVICE WAS POSITIONED TO THE BRUSH HANDLE SIDE THAN USUAL. THEREFORE THE USER STOPPED USING THE SUBJECT DEVICE. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    940815 CHANNEL-OPENING CLEANING BRUSH CHANNEL-OPENING CLEANING BRUSH MNL OLYMPUS MEDICAL SYSTEMS CORP. MH-507 9ZR 04953170023187

    Patients

    Seq Age Sex Outcome Treatment
    1