BEUDAMED
    FDA Adverse Event Summary report: N

    RELIANCE ENDOSCOPE PROCESSING SYSTEM

    MDR report key: 3897181 · Received June 26, 2014

    Report

    Report Number
    9680353-2014-00043
    Date Received
    June 26, 2014
    Date of Event
    May 30, 2014
    Report Date
    June 26, 2014
    Manufacturer
    STERIS CANADA CORPORATION
    Product Code
    NZA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE STERIS TECHNICIAN INSPECTED THE WASHER AND FOUND THAT ONE OF THE HOSES NEAR THE MIXING VALVE ASSEMBLY WAS DISCONNECTED. THE TECHNICIAN ALSO OBSERVED OTHER SMALL LEAKS. THE TECHNICIAN REPAIRED THE WASHER, RAN A TEST CYCLE AND CONFIRMED THE WASHER TO BE OPERATIONAL. NO FURTHER ISSUES HAVE BEEN REPORTED.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT WATER WAS LEAKING FROM THEIR RELIANCE ENDOSCOPE PROCESSING SYSTEM. NO INJURIES OR PROCEDURAL DELAY/CANCELLATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    373365 RELIANCE ENDOSCOPE PROCESSING SYSTEM PROCESSING SYSTEM NZA STERIS CANADA CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1