BEUDAMED
    FDA Adverse Event Summary report: N

    RELIANCE ENDOSCOPE PROCESSING SYSTEM

    MDR report key: 3872871 · Received June 13, 2014

    Report

    Report Number
    9680353-2014-00038
    Date Received
    June 13, 2014
    Date of Event
    May 17, 2014
    Report Date
    June 13, 2014
    Manufacturer
    STERIS CANADA CORPORATION
    Product Code
    NZA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A STERIS SERVICE TECHNICIAN ARRIVED AT THE FACILITY THE DAY OF THE EVENT AND FOUND THE ROOM WHERE THE RELIANCE EPS IS LOCATED WAS COMPLETELY DRY. THE TECHNICIAN INSPECTED THE UNIT AND WATER SUPPLY LINE CONNECTED TO THE PRE-FILTER ASSEMBLY AND DID NOT IDENTIFY ANY SIGNS OF LEAKAGE. THE TECHNICIAN PERFORMED A TEST CYCLE AND FOUND A SMALL AMOUNT OF WATER DRIPPING FROM THE DOOR GASKET. THE TECHNICIAN NOTED THAT THE AMOUNT OF WATER LEAKING FROM THE DOOR GASKET WOULD NOT HAVE CAUSED THE ROOM TO FLOOD AS THE FACILITY REPORTED. THE TECHNICIAN REPLACED THE DOOR GASKET, PERFORMED A TEST CYCLE AND RETURNED THE UNIT TO SERVICE. THE UNIT WAS INSTALLED IN APRIL OF 2008 AND IS CURRENTLY UNDER A STERIS SERVICE CONTRACT. THE LAST PREVENTIVE MAINTENANCE WAS COMPLETED ON APRIL 23, 2014 AT WHICH TIME THE UNIT WAS FOUND TO BE OPERATING TO SPECIFICATION. THE RELIANCE EPS HAS NOT BEEN IDENTIFIED AS THE CAUSE OF THE REPORTED FLOOD IN THIS EVENT. THE FACILITY WAS UNABLE TO IDENTIFY THE ORIGIN OF THE WATER LEAK, AND THE STERIS SERVICE TECHNICIAN DID NOT IDENTIFY ANY SIGNS OF LEAKAGE FROM THE EPS UNIT THAT WOULD HAVE RESULTED IN FLOODING OF THE FACILITY'S ROOM.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THE ROOM WHERE THEIR RELIANCE ENDOSCOPE PROCESSOR SYSTEM (EPS) IS LOCATED HAD FLOODED WITH WATER. THE CUSTOMER STATED THEY DID NOT KNOW THE ORIGIN OF THE LEAK AS THE ROOM IS ALSO EQUIPPED WITH SCRUB SINKS. THE FACILITY STATED AN EMPLOYEE SLIPPED AND FELL ON THE STANDING WATER. THE EMPLOYEE SOUGHT MEDICAL TREATMENT AT THE FACILITY'S ER. THE CUSTOMER DECLINED TO PROVIDE ADDITIONAL INFORMATION REGARDING THE EMPLOYEE'S INJURY. THE EMPLOYEE IS REPORTED TO BE BACK TO WORK WITH NO LIMITATIONS. NO PROCEDURAL DELAYS/CANCELLATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349661 RELIANCE ENDOSCOPE PROCESSING SYSTEM RELIANCE ENDOSCOPE PROCESSOR NZA STERIS CANADA CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Other