BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOW TEMPERATURE STERILIZERS

    MDR report key: 754653 · Received August 25, 2006

    Report

    Report Number
    1527821-2006-00002
    Event Type
    Injury
    Date Received
    August 25, 2006
    Date of Event
    July 26, 2006
    Report Date
    August 25, 2006
    Manufacturer
    STERIS CORPORATION
    Product Code
    FLE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    BASED UPON STERIS'S INVESTIGATION OF THE SYSTEM 1 PROCESSOR IN QUESTION, THE LID CLOSED DUE TO A FAILURE OF THE GAS/SPRING CYLINDER ON THE PROCESSOR LID. THE GAS CYLINDER FUNCTIONS TO GRADUALLY OPEN THE PROCESSOR LID AND HOLD THE LID OPEN WHILE LOADING/UNLOADING THE PROCESSING CHAMBER. AN EVALUATION OF THE GAS/SPRING CYLINDER ON THE PROCESSOR IN QUESTION INDICATES THAT THE STEEL SHAFT HAD BROKEN NEAR THE POINT OF ATTACHMENT TO THE LID. UNDER CERTAIN CONDITIONS THIS FAILURE COULD CAUSE THE LID TO CLOSE UNEXPECTEDLY. THE OPERATOR INVOLVED IN THE INCIDENT INDICATED TO STERIS THAT THE CYLINDER HAD SHOWN SIGNS OF DETERIORATION PRIOR TO THIS INCIDENT IN THAT THE GAS/SPRING CYLINDER WAS NOT CORRECTLY OPENING AND HOLDING THE LID IN THE OPEN POSITION. BASED UPON AN ANALYSIS OF COMPLAINTS OVER THE LAST 4 YEARS ON AN INSTALLED BASE OF OVER 10,000 SYSTEM 1 PROCESSORS AND OVER 50,000,000 PROCESSING CYCLES, THIS IS THE ONLY OPERATOR INJURY ASSOCIATED WITH BREAKAGE OF THE GAS SPRING CYLINER SHAFT.

    Description of Event or Problem · 1

    STERIS RECEIVED A COMPLAINT FROM REPORTER FOR ORTHO AND MULTI SPECIALTY SURGERY IN 2006, ALLEGING THAT AN INJURY HAD OCCURRED TO A HOSPITAL EMPLOYEE WHILE OPERATING A STERIS SYSTEM 1. BASED ON INFORMATION PROVIDED TO STERIS, THE OPERATOR EXPERIENCED DIFFICULTY CLOSING AND LATCHING THE PROCESSING CHAMBER LID AFTER LOADING A STERIS 20 STERILANT CUP IN THE SYSTEM 1 PROCESSOR. THE OPERATOR OPENED THE PROCESSOR LID TO DISPOSE OF THE STERIS 20 STERILANT, REMOVED THE ASPIRATOR ASSEMBLY FROM THE STERILANT CUP, AND SET THE ASPIRATOR ON THE TRAY WITH THE STEM POINTING UPWARD. THE OPERATOR ALLEGES THAT THE PROCESSOR LID CLOSED SUDDENLY WHILE HIS HAND WAS OVER THE STEM OF THE ASPIRATOR, AND THE STEM OF THE ASPIRATOR PUNCTURED HIS HAND. THE OPERATOR WAS TREATED WITHY FIRST AID, A BANDAGE (NO STITCHES), ANTIBIOTICS, AND PAIN MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LOW TEMPERATURE STERILIZERS * FLE STERIS CORPORATION 1271720 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other| R