BEUDAMED
    FDA Adverse Event Other Summary report: N

    STERIS SYSTEM ONE

    MDR report key: 747139 · Received October 27, 2005

    Report

    Report Number
    MW1037039
    Event Type
    Other
    Date Received
    October 27, 2005
    Date of Event
    October 17, 2005
    Report Date
    October 27, 2005
    Manufacturer
    STERIS CORP.
    Product Code
    FLE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ENDOSCOPY REPORTS A STERIS SYSTEM ONE STERILIZATION REPROCESSING MACHINE WAS IN THE RINSE CYCLE WHEN WATER STARTED "GUSHING" OUT OF THE SIDES. THE LID DID NOT POP OPEN. NO INJURIES, THERE WAS NO STERILANT IN THE MACHINE. MACHINE TAKEN OUT OF SERVICE, A NEW LID GASKET WAS INSTALLED BY CERTIFIED MEDICAL ENGINEER SERVICE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other