BEUDAMED
    FDA Adverse Event Other Summary report: N

    AMSCO STERILIZING UNIT

    MDR report key: 408477 · Received July 31, 2002

    Report

    Report Number
    MW1025723
    Event Type
    Other
    Date Received
    July 31, 2002
    Date of Event
    June 21, 2002
    Report Date
    July 25, 2002
    Manufacturer
    STERIS CORP
    Product Code
    FLE
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE AUTOCLAVE STERILIZATION OF PLATES FOR ORBITAL FRACTURE FIXATION DID NOT REACH OPTIMAL TEMP OF 270. THE TEMP REACHED 253 FOR 15 MINS. THE CYCLE WAS RUN ON GRAVITY NOT ON FLASH CYCLE. THE MACHINE FUNCTIONED CORRECTLY. MAINTENANCE WAS CALLED AND COULD NOT FIND PROBLEM WITH AUTOCLAVE. PROCEDURE REGARDING AUTOCLAVE WAS NOT FOLLOWED. (THE ORBITAL FRACTURE PLATE WAS PLACED ON THE OR FIELD, BUT WAS NOT USED IN THE PROCEDURE.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMSCO STERILIZING UNIT AMSCO STERILIZING UNIT FLE STERIS CORP AMSCO V116 *

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Other