BEUDAMED
    FDA Adverse Event Injury Summary report: N

    16" STG 2 PIWS

    MDR report key: 1040280 · Received May 8, 2008

    Report

    Report Number
    2515984-2008-00008
    Event Type
    Injury
    Date Received
    May 8, 2008
    Date of Event
    April 9, 2008
    Report Date
    April 28, 2008
    Manufacturer
    STERIS CORPORATION
    Product Code
    FLE
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CYCLE WAS ABNORMALLY LONG DUE TO RESTRICTION IN THE STEAM LINE. ADDITIONALLY, THE LINE WAS COMPLETED BLOCKED BY DEBRIS FROM THE HOSP BOILER. THIS CONDITION CAUSED STEAM TO REMAIN IN THE CHAMBER. WHEN THE DOOR WAS OPENED, THE STEAM CAME OUT CAUSING THE INJURY. AFTER REPAIR BY FIELD SERVICE TECHNICIAN, THE CONDITION PHASE WAS LESS THAN 3 MINUTES. NO OTHER PROBLEMS WERE FOUND. DRY TIME WAS RAISED FROM 1 TO 5 MINUTES. IT IS NOT RELATED TO A MANUFACTURING ISSUE. THE CUSTOMER MAINTENANCE DEPT WILL CONDUCT APPROPRIATE PERIODIC MAINTENANCE AND INSPECTION OF THE STEAM SUPPLY AND BOILER. OPERATORS SHALL OBSERVE THE SUMMARY OF THE SAFETY PRECAUTIONS WHEN OPERATING THE WASHER/STERILIZER AS DOCUMENTED IN THE OPERATIVE MANUAL EAGLE 2014 16"X16"X26" WASHER/STERILIZER/DECONTAMINATOR P-129218-001.

    Description of Event or Problem · 1

    THE CONDITION PHASE WAS TAKING ABNORMALLY LONG, 17-18 MINUTES. WHEN THE CYCLE WAS COMPLETED AND THE DOOR WAS OPENED, STEAM VAPOR BURNED THE RIGHT EYE OF THE OPERATOR. THE EXTENDED CONDITION PHASE WAS CAUSED BY RESTRICTION IN THE HOSP STEAM LINE. OPERATOR SAW THE DR, WHO SAID THAT HER EYE WAS FINE. NO PERMANENT INJURY. THE OPERATOR RETURNED AFTER TWO DAYS OFF WORK. WARNING LABELS: WARNING LABEL AND CAUTION LABELS WERE LOCATED ON THE DOOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 16" STG 2 PIWS STERILIZER FLE STERIS CORPORATION 1045013 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention