BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3012 PIWS 16X16X26"

    MDR report key: 1007207 · Received March 6, 2008

    Report

    Report Number
    2515984-2008-00003
    Event Type
    Injury
    Date Received
    March 6, 2008
    Date of Event
    February 9, 2008
    Report Date
    March 3, 2008
    Manufacturer
    STERIS CORPORATION
    Product Code
    MLR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    IT APPEARS TO BE A CASE OF OPERATOR ERROR WHEN REACHED INTO THE STERILIZER AT THE END OF THE CYCLE TO INSERT A SPORE STRIP AND BURNED HER FINGERS, ONCE THAT WAS A HOT LOAD INSIDE OF THE STERILIZER. IT WAS ALSO NOTED THAT THE UNIT WAS EQUIPPED WITH THE INDICATED HOT SURFACE DECAL AS WAS REPORTED BY THE STERIS SERVICE TECH. OPERATOR SHOULD WEAR PROPER PPE WHEN LOADING/UNLOADING STERILIZER CHAMBER. "STERILIZER DOES NOT REPORT ANY MALFUNCTION." THE MANUAL OPERATOR FOR EQUIPMENT MANUAL 16" PIWS MAKES MENTION OF A SUMMARY ON SAFETY PRECAUTIONS TO BE OBSERVED WHEN THIS EQUIPMENT IS OPERATED AND BEHIND UPPER ACCESS PANEL OF THE UNIT. SUMMARY OF SAFETY CAUTIONS, WARNINGS, BURN HAZARD: "ALLOW WASHER/STERILIZER AND ACCESSORIES TO COOL TO ROOM TEMPERATURE BEFORE PERFORMING ANY CLEANING OR MAINTENANCE PROCEDURES". ALSO IS MENTIONED - BURN HAZARD: "WASHER/STERILIZER AND RACK/SHELVES WILL BE HOT AFTER CYCLE IS RUN. ALWAYS WEAR PROTECTIVE GLOVES AND APRON WHEN REMOVING A PROCESSED LOAD. PROTECTIVE GLOVES AND APRON SHOULD ALSO BE WORN WHEN RELOADING WASHER/STERILIZER FOLLOWING THE PREVIOUS OPERATION."

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3012 PIWS 16X16X26" STERILIZER MLR STERIS CORPORATION 1041017 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention