BEUDAMED
    FDA Adverse Event Summary report: N

    EAGLE STERILIZER

    MDR report key: 2094284 · Received May 18, 2011

    Report

    Report Number
    3005899764-2011-00014
    Date Received
    May 18, 2011
    Date of Event
    February 9, 2011
    Report Date
    May 18, 2011
    Manufacturer
    STERIS MEXICO, S. DE R.L. DE C.V.
    Product Code
    FLE
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    STERIS RECEIVED MEDWATCH FORM 3500A ON (B)(4) 2011. THE USER FACILITY, (B)(6), REPORTED THAT A SCOPE HANDLE HAD MELTED AFTER IT WAS PROCESSED IN AN AMSCO EAGLE 3043 STERILIZER. UPON RECEIPT OF THE MEDWATCH STERIS INVESTIGATED THE REPORTED EVENT AND DISCOVERED THAT IT WAS NOT THE SCOPE HANDLE THAT MELTED IN THE STERILIZER BUT RATHER A SCOPE HANDLE COVER. THE USER FACILITY REPORTED TO STERIS THAT THE EVENT WAS DUE TO OPERATOR ERROR AS THE OPERATOR HAD MISTAKENLY LOADED THE SCOPE HANDLE COVER IN THE STERILIZER FOR PROCESSING. THE SCOPE HANDLE COVER IS PLASTIC AND NOT SUITABLE TO BE PROCESSED IN THE STERILIZER. THE USER FACILITY ALSO REPORTED THE STERILIZER IS OPERATING PROPERLY AND HAS REMAINED IN USE. NO FURTHER ISSUES HAVE BEEN REPORTED.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EAGLE STERILIZER STEAM STERILIZER FLE STERIS MEXICO, S. DE R.L. DE C.V.

    Patients

    Seq Age Sex Outcome Treatment
    1