BEUDAMED
    FDA Adverse Event Summary report: N

    RELIANCE ENDOSCOPE PROCESSOR

    MDR report key: 5014622 · Received August 19, 2015

    Report

    Report Number
    9680353-2015-00050
    Date Received
    August 19, 2015
    Date of Event
    May 29, 2015
    Report Date
    August 19, 2015
    Manufacturer
    STERIS CANADA CORPORATION
    Product Code
    NZA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION OF THIS EVENT IS CURRENTLY IN PROCESS. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    A STERIS SERVICE TECHNICIAN ARRIVED ONSITE AND CONFIRMED THAT THE USER FACILITY HAS THREE RELIANCE ENDOSCOPE PROCESSING SYSTEMS. THE TECHNICIAN INSPECTED THE UNITS AND FOUND THAT THE UNITS WERE ALARMING A FAULT 02. FAULT 02 PROMPTS THE USER TO INSPECT/CHANGE THE A&B FILTERS CARTRIDGES. THE TECHNICIAN REPLACED THE FILTERS AND COLLECTED A WATER SAMPLE. THE WATER SAMPLES WERE SENT FOR ANALYSIS AND INDICATED THAT THE USER FACILITY HAS ELEVATED COPPER LEVELS IN THEIR WATER. THE TECHNICIAN COMMUNICATED THE RESULTS OF THE WATER ANALYSIS WITH THE USER FACILITY. THE USER FACILITY STATED TO THE STERIS TECHNICIAN THAT THEIR RELIANCE ENDOSCOPE PROCESSING SYSTEMS ARE OPERATING TO SPECIFICATION AND NO ISSUES HAVE BEEN NOTED. THE STERIS ACCOUNT MANAGER MADE MULTIPLE ATTEMPTS TO MEET WITH USER FACILITY PERSONNEL TO DISCUSS THE REPORTED EVENT AND FINDINGS HOWEVER, THE USER FACILITY WAS UNRESPONSIVE. THEREFORE, IT IS UNKNOWN IF THE USER FACILITY CORRECTED THE ISSUE WITH THEIR INCOMING WATER QUALITY.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED VIA MW5042957 MULTIPLE FAILURES ON THEIR RELIANCE EPS CAUSING DELAYS IN PATIENT PROCEDURES AND WORKFLOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    548281 RELIANCE ENDOSCOPE PROCESSOR ENDOSCOPE PROCESSOR NZA STERIS CANADA CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1