BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCOPE BUDDY PLUS

    MDR report key: 12091721 · Received June 30, 2021

    Report

    Report Number
    12091721
    Event Type
    Malfunction
    Date Received
    June 30, 2021
    Date of Event
    May 27, 2021
    Report Date
    June 25, 2021
    Manufacturer
    MEDIVATORS INC.
    Product Code
    FEB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    MANUAL CLEANING DEVICE IN REPROCESSING NOTED TO HAVE CRACKED "DETERGENT OUT" CONNECTION WITH LUER LOCK CONNECTOR LOOSE AND HANGING OUT OF MACHINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    992368 SCOPE BUDDY PLUS ACCESSORIES, CLEANING, FOR ENDOSCOPE FEB MEDIVATORS INC. SPB-1000

    Patients

    Seq Age Sex Outcome Treatment
    1