BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOQUICK DETERGENT

    MDR report key: 11412014 · Received March 4, 2021

    Report

    Report Number
    11412014
    Event Type
    Malfunction
    Date Received
    March 4, 2021
    Date of Event
    February 22, 2021
    Report Date
    February 26, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FEB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    INCIDENT DESCRIPTION: AROUND 1400: ENDOSCOPY STAFF WERE CHANGING OUT SOME ENDOQUICK IN THE SCOPE WASHING OER PRO MACHINES. WHEN THE CAP WAS TAKEN OFF THE ENDOQUICK, STAFF NOTICED SOME UNKNOWN DEBRIS FLOATING INSIDE. RIGHT AWAY STAFF AGREED TO OPEN ANOTHER BOTTLE OF ENDOQUICK AND NOTICED THE FLOATING DEBRIS INSIDE THAT BOTTLE. ALSO NOTICED MORE DEBRIS INSIDE THE ENDOQUICK BOTTLES THAT WERE ALREADY BEING USED FROM THE EARLIEST DATE (WEEK PRIOR). THEN STAFF LOOKED AT THE LOT NUMBERS AND NOTICED ALL THE BOTTLES THAT HAD THIS DEBRIS INSIDE ALL HAD THE SAME LOT NUMBER (203511) AND EXPIRATION DATE (2022-06-30). STAFF CHECKED THE REST OF THE ENDOQUICK BOTTLES AND FOUND SOME WITH A DIFFERENT LOT NUMBER. OPENED ONE BOTTLE AND THERE WAS NOT DEBRIS. OPENED TWO MORE BOTTLES WITH THE SAME LOT NUMBER AS THE FIRST ONE THAT HAD NO DEBRIS, AND THEY HAD NO DEBRIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308901 ENDOQUICK DETERGENT ACCESSORIES, CLEANING, FOR ENDOSCOPE FEB OLYMPUS MEDICAL SYSTEMS CORP. 203511

    Patients

    Seq Age Sex Outcome Treatment
    1