BEUDAMED
    FDA Adverse Event Summary report: N

    RELIANCE EPS

    MDR report key: 2625071 · Received June 21, 2012

    Report

    Report Number
    9680353-2012-00039
    Date Received
    June 21, 2012
    Date of Event
    May 22, 2012
    Report Date
    June 21, 2012
    Manufacturer
    STERIS CANADA CORPORATION
    Product Code
    NZA
    PMA / PMN Number
    K102244
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A STERIS SERVICE TECHNICIAN INSPECTED THE UNIT AND FOUND THAT THE DOOR GASKET HAD BECOME MISALIGNED FROM THE HOLDING PLATE, RESULTING IN THE REPORTED LEAK. THE TECHNICIAN REINSTALLED THE GASKET AND CLEANED BUILDUP THAT WAS NOTED WHERE THE DOOR AND GASKET MEET. THE TECHNICIAN ALSO CLEANED DEBRIS FROM THE DRIP PAN STRAINER. THE TECHNICIAN TESTED THE UNIT AND IT TO SERVICE; NO FURTHER ISSUES HAVE BEEN REPORTED. THE WASHER IS NOT UNDER STERIS SERVICE CONTRACT AND IS SERVICED BY A THIRD PARTY. THE EQUIPMENT MAINTENANCE MANUAL STATES (PP. 4-1): "CHECK DOOR GASKET FOR WEAR AND TEAR. VERIFY GASKET IS PROPERLY INSERTED IN DOOR FRAME. REPLACE IF NECESSARY. (3X/YEAR)." THE EQUIPMENT MAINTENANCE MANUAL FURTHER STATES (PP. 4-27) HOW TO CLEAN THE DOOR DRIP PAN STRAINER LOCATED IN FRONT OF THE UNIT. STERIS HAS ADVISED THE USER FACILITY ON PERFORMING SCHEDULED MAINTENANCE ON THEIR EQUIPMENT.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THE RELIANCE ENDOSCOPE PROCESSOR WAS LEAKING WATER. USER FACILITY PERSONNEL SHUT OFF THE UNIT AND CLEANED UP THE WATER. NO INJURIES, PROCEDURAL DELAYS/CANCELLATIONS OR PROPERTY DAMAGE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RELIANCE EPS WASHER/DISINFECTOR NZA STERIS CANADA CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Other