BEUDAMED
    FDA Adverse Event Summary report: N

    RELIANCE ENDOSCOPE PROCESSING SYSTEM

    MDR report key: 5098802 · Received September 23, 2015

    Report

    Report Number
    9680353-2015-00061
    Date Received
    September 23, 2015
    Date of Event
    September 1, 2015
    Report Date
    September 23, 2015
    Manufacturer
    STERIS CANADA CORPORATION
    Product Code
    NZA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FACILITY REPORTED THE CHEMICAL DELIVERY SYSTEM (CDS) DISPENSE CANISTERS WERE DISINTEGRATING/ ERODING. THE FACILITY STATED THE EROSION OF THE CANISTERS PRODUCED A CHALK-LIKE SUBSTANCE WHICH WAS UNABLE TO PASS THROUGH ALL OF THE WATER/AIR CHANNELS IN SOME OF THE SCOPES PROCESSED IN THE EPS UNIT. DUE TO THE PRESENCE OF THE CHALK-LIKE SUBSTANCE IN THE SCOPES, THE FACILITY REPROCESSED ALL SCOPES AND VERIFIED THAT THE UNITS WERE FREE FROM CHEMICALS PRIOR TO USE IN PATIENT PROCEDURES. A SERVICE TECHNICIAN ARRIVED AT THE USER FACILITY, INSPECTED THE RELIANCE EPS UNIT AND CONFIRMED THE CUSTOMER WAS USING THE CORRECT, COMPATIBLE STERIS HLD/DG DETERGENT WITH THE RELIANCE EPS. THE TECHNICIAN REVIEWED CYCLE PRINTOUTS FROM THE DAY AND STATED NO ALARMS OR ABORTS HAD OCCURRED. THE RELIANCE EPS OPERATOR MANUAL STATES, "4.3 POST-PROCESSING CHECKLIST: RELIANCE DRY CHEMISTRY CONTAINER AND RELIANCE CDS CHEMICAL DELIVERY SYSTEM VERIFIED FOR ABSENCE OF SOLID RESIDUE." THE TECHNICIAN REPLACED THE DISPENSE CANISTERS, TESTED THE UNIT FOR CORRECT OPERATION AND RETURNED THE UNIT TO SERVICE. THE DISPENSE CANISTERS WERE REQUESTED FOR FURTHER EVALUATION; HOWEVER AT THIS TIME THE CUSTOMER HAS STATED THAT THE CANISTERS ARE NOT AVAILABLE. FOLLOWING THE EVENT, THE FACILITY STATED THEIR SERVICE PROVIDER INDICATED THEY WERE AWARE OF THE ERODING ISSUE WITHIN THE RELIANCE EPS UNIT, HOWEVER DID NOT REPLACE THE CANISTERS WHEN THE ISSUE WAS OBSERVED. THE FACILITY'S SERVICE PROVIDERS HAVE SINCE BEEN INSTRUCTED TO REPLACE THE DISPENSE CANISTERS IMMEDIATELY SHOULD DISINTEGRATION/ERODING BE OBSERVED. NO FURTHER ISSUES HAVE BEEN REPORTED.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED AN ISSUE WITH THE CHEMICAL DELIVERY SYSTEM LOCATED WITHIN THE RELIANCE EPS UNIT. NO INJURY OR PROCEDURAL DELAY OR CANCELLATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    628471 RELIANCE ENDOSCOPE PROCESSING SYSTEM ENDOSCOPE PROCESSOR NZA STERIS CANADA CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1