BEUDAMED
    FDA Adverse Event Other Summary report: N

    STERIS SYSTEM PROCESSOR

    MDR report key: 115135 · Received August 21, 1997

    Report

    Report Number
    115135
    Event Type
    Other
    Date Received
    August 21, 1997
    Date of Event
    August 13, 1997
    Report Date
    August 19, 1997
    Manufacturer
    STERIS CORP
    Product Code
    FLE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE SPRING DISLODGED FROM THE STERIS DOOR LATCH DURING THE BEGINNING OF THE STERILIZATION PROCESS. THE RISE IN PRESSURE FORCED THE DOOR LATCH TO OPEN, SPEWING PEROXYACETIC ACID (EPA REG. #58779-1) OVER THE ENTIRE ROOM. VAPORS FROM THE STERILANT PENETRATED THE OPERATIVE SUITE WITH SUBSEQUENT EXPOSURE TO EMPLOYEES. ONE EMPLOYEE REQUIRED EMERGENCY TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERIS SYSTEM PROCESSOR STERILIZING UNIT FLE STERIS CORP 89A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other