BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERIS SYSTEM ONE

    MDR report key: 511033 · Received February 3, 2004

    Report

    Report Number
    MW1031013
    Event Type
    Malfunction
    Date Received
    February 3, 2004
    Date of Event
    December 16, 2003
    Report Date
    December 18, 2003
    Manufacturer
    STERIS CORP
    Product Code
    FLE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE LID POPPED UP DURING PROCESSING OF ENDOSCOPE AND THE STERILANT WENT ALL OVER THE TECHNICIAN. THE SEAL BLEW AROUND THE LID AND THE MACHINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERIS SYSTEM ONE STERILIZATION MACHINE ENDOSCOPY REPROCESSING SYSTEM FLE STERIS CORP STERIS 1 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other