BEUDAMED
    FDA Adverse Event Summary report: N

    STERIS SYSTEM 1E

    MDR report key: 2880188 · Received December 19, 2012

    Report

    Report Number
    3000251274-2012-00271
    Date Received
    December 19, 2012
    Date of Event
    December 5, 2012
    Report Date
    December 19, 2012
    Manufacturer
    STERIS CORPORATION - HOPKINS
    Product Code
    MED
    PMA / PMN Number
    K090036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SYSTEM 1E SUBJECT OF THE REPORTED EVENT WAS RETURNED TO STERIS QUALITY FOR EVALUATION. EVALUATION RESULTS CONCLUDED: (1) OUTSIDE SURFACES OF THE SYSTEM 1E INCLUDING THE LID, LID RELEASE AND BOTTOM SHROUD WERE IN GOOD CONDITION; (2) LID WAS ALIGNED TO THE DRIP PAN; (3) THE HANDLE PULLED AND THE LID OPENED EASILY AND SLOWLY ROSE TO ITS FULL HEIGHT; (4) THE INSIDE OF THE CHAMBER WAS IN GOOD CONDITION; (5) DRIP PAN OVAL CUTOUTS AND LID HOOKS WERE IN GOOD CONDITION. MULTIPLE DIAGNOSTIC AND PROCESSING CYCLES WERE RUN AND COMPLETED WITHOUT ISSUES.

    Additional Manufacturer Narrative · 1

    A STERIS SERVICE TECHNICIAN ARRIVED ONSITE AND INSPECTED THE UNIT AND COULD NOT FIND AN ISSUE WITH THE LID. THE TECHNICIAN RAN A DIAGNOSTIC CYCLE WHICH COMPLETED SUCCESSFULLY AND FOUND THE SEAL DEFLATED AND LID OPENED WITHOUT ISSUE. HE THEN RAN A PROCESSING CYCLE AND FOUND THE SEAL DEFLATED AND LID OPENED WITHOUT ISSUE. THE TECHNICIAN THEN PLACED THE UNIT IN SERVICE MODE. 12 TIMES IN SUCCESSION HE: INFLATED THE SEAL, ENERGIZED THE LID RELEASE VALVE AND OPENED THE LID WITHOUT ISSUE. INVESTIGATION OF THIS EVENT IS CURRENTLY IN PROCESS; A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT AN EMPLOYEE APPLIED PRESSURE TO THEIR SYSTEM 1E LID IN AN ATTEMPT TO OPEN THE LID AND RECEIVED AN INJURY. THE EMPLOYEE SUSTAINED 3 BROKEN RIBS. THE EMPLOYEE RETURNED TO WORK THE FOLLOWING DAY AND MISSED NO ADDITIONAL TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERIS SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM MED STERIS CORPORATION - HOPKINS

    Patients

    Seq Age Sex Outcome Treatment
    1