BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIRST-STEP ENDOSCOPE BEDSIDE PRE-CLEAN KIT

    MDR report key: 7850190 · Received September 6, 2018

    Report

    Report Number
    7850190
    Event Type
    Malfunction
    Date Received
    September 6, 2018
    Date of Event
    August 23, 2018
    Report Date
    August 24, 2018
    Manufacturer
    CYGNUS MEDICAL LLC
    Product Code
    MNL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING PRE-CLEANING OF ENDOSCOPE, THE PACKAGE OF FIRST STEP WILL NOT OPEN WHEN TORN ALONG THE PERFORATION. THIS FORCES ONE TO USE EXTRA STRENGTH TO TEAR IT OPEN, AND WHEN DONE IT SPLASHES THE ENZYMATIC SOLUTION UP IN THE AIR AND TOWARDS FACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    693432 FIRST-STEP ENDOSCOPE BEDSIDE PRE-CLEAN KIT ACCESSORIES, CLEANING BRUSHES, FOR ENDOSCOPE MNL CYGNUS MEDICAL LLC

    Patients

    Seq Age Sex Outcome Treatment
    1