BEUDAMED
    FDA Adverse Event Summary report: N

    RELIANCE EPS ENDOSCOPE PROCESSING SYSTEM

    MDR report key: 6089893 · Received November 9, 2016

    Report

    Report Number
    9680353-2016-00111
    Date Received
    November 9, 2016
    Date of Event
    October 10, 2016
    Report Date
    November 9, 2016
    Manufacturer
    STERIS CANADA CORPORATION
    Product Code
    NZA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A STERIS SERVICE TECHNICIAN ARRIVED ON-SITE, INSPECTED THE UNIT, AND IDENTIFIED THE CRIMP HOLDING THE HOSE TO THE HOT WATER SUPPLY VALVE FAILED CAUSING THE HOSE TO BECOME DETACHED. THE TECHNICIAN REPLACED THE CRIMP, TESTED THE UNIT, AND CONFIRMED IT TO BE OPERATING ACCORDING TO SPECIFICATION. UPON FURTHER INVESTIGATION, THE TECHNICIAN IDENTIFIED THE USER FACILITY'S WATER PRESSURE WAS OUT OF SPECIFICATION, CAUSING THE CRIMP ON THE WATER SUPPLY VALVE TO FAIL. NO ADDITIONAL ISSUES HAVE BEEN IDENTIFIED.

    Description of Event or Problem · 1

    THE USER FACILITY STATED THAT A HOT WATER SUPPLY HOSE ON THEIR RELIANCE EPS BECAME DETACHED FROM THE WALL CAUSING A WATER LEAK. PROCEDURE DELAYS OCCURRED AS A RESULT OF THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    739875 RELIANCE EPS ENDOSCOPE PROCESSING SYSTEM PROCESSING SYSTEM NZA STERIS CANADA CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Other