BEUDAMED
    FDA Adverse Event Summary report: N

    STERIS SYSTEM 1

    MDR report key: 1660017 · Received April 15, 2010

    Report

    Report Number
    3000251274-2010-00012
    Date Received
    April 15, 2010
    Date of Event
    January 12, 2010
    Report Date
    April 15, 2010
    Manufacturer
    STERIS CORPORATION - HOPKINS
    Product Code
    MED
    PMA / PMN Number
    K875280
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    STERIS IS NOT AWARE OF ANY ADVERSE CLINICAL EVENT ASSOCIATED WITH THIS INCIDENT OR A MALFUNCTION OF THE SYSTEM 1 PROCESSOR. IT WAS REPORTED THAT THE AFFECTED OLYMPUS 160 SERIES BRONCHOSCOPES WERE NOT USED IN PATIENT PROCEDURES. A STERIS SERVICE TECHNICIAN INSPECTED THE SYSTEM 1 PROCESSOR AND VERIFIED THAT IT WAS OPERATING PROPERLY; BOTH THE DIAGNOSTIC AND STERILE TEST CYCLES PASSED. THE PROCESSOR IS MAINTAINED AND SERVICED BY THE FACILITY BIOMEDICAL DEPARTMENT. STERIS CLINICAL EDUCATION SPECIALIST VISITED THE USER FACILITY TO OBSERVE THEIR SCOPE PROCESSING AND CLEANING PRACTICES. THE CLINICAL SPECIALIST OBSERVED THAT THE USER FACILITY DOES NOT MEASURE THE WATER USED TO DILUTE THE ENZYME CLEANER DURING SCOPE CLEANING IN ACCORDANCE WITH THE CYGNUS MEDICAL ENDOPACK PRE-CLEAN KIT LABELING WHICH REQUIRES 3 GALLONS OF WATER PER PACKET. IN ADDITION, THE FACILITY USES HOT WATER TO DILUTE THE ENZYME CLEANER, AND DOES NOT RINSE OFF THE CLEANER/WATER SOLUTION FROM THE SCOPE UPON COMPLETION OF PRE-CLEANING. (B)(4). AS PREVIOUSLY NOTED, STERIS HAS PERFORMED MATERIAL COMPATIBILITY TESTING RELATIVE TO THE OLYMPUS SERIES 160 BRONCHOSCOPES AS PART OF OUR DEVICE TESTING AND VALIDATION PROGRAM. THAT TESTING SHOWED NO FLAKING OR PEELING OF THE INSERTION TUBE AS A RESULT OF PROCESSING IN SYSTEM 1 FOR 300 CYCLES. IN ADDITION, OLYMPUS LABELING DOES NOT RESTRICT THE USE OF THE OLYMPUS 160 SERIES BRONCHOSCOPES IN SYSTEM 1. DEVICE MANUFACTURING OR CUSTOMER USE/HANDLING ISSUES THAT CAN CONTRIBUTE TO PREMATURE DEGRADATION OF ENDOSCOPES INCLUDE: PRE-CLEANING PRACTICES - UTILIZING HARSH OR INCOMPATIBLE PRE-CLEANING MATERIALS (STERIS RECOMMENDS UTILIZING STERIS'S ENZYMATIC CLEANER), MANUFACTURING OR QUALITY ISSUES WITH THE ENDOSCOPE, AND/OR THIRD PARTY REPAIRS THAT UTILIZE INCOMPATIBLE MATERIAL.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERIS SYSTEM 1 STERIS SYSTEM 1 MED STERIS CORPORATION - HOPKINS P6000

    Patients

    Seq Age Sex Outcome Treatment
    1 Other