BEUDAMED
    FDA Adverse Event Summary report: N

    VERIFY SIXCESS 270F 4 MINUTE INDICATOR

    MDR report key: 2471213 · Received February 28, 2012

    Report

    Report Number
    8021896-2012-00001
    Date Received
    February 28, 2012
    Date of Event
    January 12, 2012
    Report Date
    February 28, 2012
    Manufacturer
    ALBERT BROWNE LTD
    Product Code
    JOJ
    PMA / PMN Number
    K070461
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY REPORTED AN INDICATOR EVIDENCED INCONCLUSIVE RESULTS AFTER A CYCLE WAS COMPLETED IN THE AUTOCLAVE DUE TO THE LAMINATE SEPARATING FROM THE INDICATOR BACKING, ALLOWING MOISTURE TO CONTACT THE INDICATOR. INSTRUMENTS WERE REPROCESSED PRIOR TO USE IN PATIENT PROCEDURES. A STERIS TECHNICIAN INSPECTED THE AUTOCLAVE FOR PROPER OPERATION, AND VERIFIED CALIBRATION AND CYCLE PRINTOUTS; NO ISSUES NOTED. THE UNIT WAS OPERATING ACCORDING TO SPECIFICATIONS. THE AUTOCLAVE WAS MANUFACTURED IN 1978 AND IS MAINTAINED AND SERVICED BY A THIRD PARTY BIOMEDICAL PROVIDER. THE DEVICE EXCEEDS ITS ESTIMATED USEFUL LIFE; STERIS HAS RECOMMENDED THE USER FACILITY REPLACE IT DUE TO ITS AGE. RETENTION TESTING WAS COMPLETED ON THE LOT SUBJECT OF THE REPORTED EVENT AND EVIDENCED PASSING RESULTS. THE TESTING INCLUDED A VISUAL INSPECTION AND TEST CYCLES RUN IN A STERILIZER FOR 20 RETAIN SAMPLES. NO ISSUES WERE NOTED AND UPON COMPLETION OF CYCLES, THE INDICATOR LAMINATE WAS STILL PRESENT AND NO SEPARATION WAS NOTED. THE DHR EVIDENCES THE LOT WAS MANUFACTURED TO SPECIFICATION. STERIS HAS DETERMINED THIS TO BE AN ISOLATED EVENT.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERIFY SIXCESS 270F 4 MINUTE INDICATOR CHEMICAL INDICATOR JOJ ALBERT BROWNE LTD 020460

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Other