BEUDAMED
    FDA Adverse Event Summary report: N

    STERIS SYSTEM 1E

    MDR report key: 4200475 · Received October 24, 2014

    Report

    Report Number
    3000251274-2014-00079
    Date Received
    October 24, 2014
    Date of Event
    September 25, 2014
    Report Date
    October 24, 2014
    Manufacturer
    STERIS CORPORATION - HOPKINS
    Product Code
    MED
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A STERIS SERVICE TECHNICIAN INSPECTED THE PROCESSOR AND FOUND THE WATER LEAK TO BE COMING FROM THE UV LIGHT. THE TECHNICIAN DISASSEMBLED THE UV LIGHT SYSTEM AND FOUND THAT THERE WAS A 3" CRACK IN THE UV LIGHT QUARTZ SLEEVE. THE TECHNICIAN REPLACED THE QUARTZ SLEEVE AND SEALING O-RINGS, RAN DIAGNOSTIC AND PROCESSING CYCLES AND CONFIRMED THE PROCESSOR TO BE OPERATING PROPERLY. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT WATER WAS LEAKING FROM THEIR SYSTEM 1E. NO INJURIES OR PROCEDURAL DELAYS OR CANCELLATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    678768 STERIS SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM MED STERIS CORPORATION - HOPKINS

    Patients

    Seq Age Sex Outcome Treatment
    1