BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERRAD 100NX STERILIZER

    MDR report key: 1203260 · Received October 17, 2008

    Report

    Report Number
    2084725-2008-00671
    Event Type
    Malfunction
    Date Received
    October 17, 2008
    Date of Event
    September 17, 2008
    Report Date
    September 17, 2008
    Manufacturer
    JABIL
    Product Code
    MLR
    PMA / PMN Number
    K071385
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER: CAPITAL EQUIPMENT, EVALUATED AT CUSTOMER SITE. THE FSE FOUND UNIT OPERATING NORMALLY AS IT SHOULD BE. THE CUSTOMER INFORMED THE FSE THAT HE HAD PERFORMED HIS OWN INVESTIGATION AND FOUND THAT THEIR PROCESS WAS FLAWED IN THAT THEY EITHER LEFT THESE SCOPES IN THE ENZYMATIC SOLUTION FAR TOO LONG, OR DID NOT RINSE WELL ENOUGH. THE CUSTOMER PROVED THIS BY RUNNING THESE SAME SCOPES THROUGH THE SYSTEM ONE UNIT AND THEY CAME OUT WITH THE SAME RESULT. THEY ARE NOW RINSING THESE SCOPES BEFORE PLACING THEM IN THE STERRAD 100NX AND THEY ARE BEING PROCESSED NORMALLY. THE FSE WATCHED AS A LOAD COMPLETED. THE CUSTOMER STATED THAT HE KNOWS NOW THAT THIS PROBLEM WAS NEVER THE FAULT OF THE STERRAD 100NX AND THE PROCESS HAS BEEN CHANGED TO INCLUDE A MORE ROBUST RINSE TO REMOVE THE ENZYMATIC PRIOR TO PROCESSING THEM IN THE STERRAD 100NX. THIS UNIT IS OPERATING AS IT SHOULD BE. REFERENCE MDRS: 2084725-2008-00666, 667, 668, 669, 670, 672, 673, 674, 675, 676, 677, 678, 679, 680, 681.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THAT THE SIXTEEN LARYNGOSCOPES THAT WERE PROCESSED IN THE STERRAD 100NX AT DIFFERENT TIMES WERE DAMAGED. THE RUBBER NEAR THE EYE PIECE BUBBLED AND, THE AREA WHERE THE ELECTRODE TURNED GREY AND ROUGH IN TEXTURE. THE CUSTOMER STATED THAT THE SCOPES ARE CLEANED FIRST BY RINSING UNDER RUNNING WATER, THEN A SOLUTION IS PREPARED WITH HALF PUMP OF SCOPE-ZYME ENZYMATIC DETERGENT IN ONE GALLON WATER. THEY ARE THEN RINSED UNDER RUNNING WATER. THE SCOPES ARE ALSO PROCESSED IN TYVEK POUCHES. IT WAS ALSO REPORTED THAT THE CUSTOMER CONTACTED THE MANUFACTURER, WHICH STATED THAT THESE SCOPES WERE COMPATIBLE IN THE STERRAD. THERE WERE NO REPORTS OF PHYSICAL COMPLAINTS RELATED TO THE DAMAGE. THE ASP FIELD SERVICE ENGINEER (FSE) WENT TO THE FACILITY TO ASSESS THE UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERRAD 100NX STERILIZER STERILIZER, CHEMICAL MLR JABIL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA TYVEK POUCH| SCOPE-ZYME ENZYMATIC DETERGENT| MACINTOSH LARYNGOSCOPE CATALOG: #4