BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SKYTRON INTEGRITY 270

    MDR report key: 8591145 · Received May 8, 2019

    Report

    Report Number
    3009685834-2019-00001
    Event Type
    Malfunction
    Date Received
    May 8, 2019
    Date of Event
    May 30, 2017
    Report Date
    April 1, 2019
    Manufacturer
    SAKURA SEIKI CO., LTD. CHIKUMA FACTORY
    Product Code
    FLE
    UDI-DI
    10841736100117
    PMA / PMN Number
    K132439
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS A PRECAUTIONARY SUBMISSION. THERE ARE NO US MARKETED SKYTRON INTEGRITY STEAM STERILIZERS WITH ANY SIMILAR INCIDENTS. THE (B)(6) INCIDENTS WERE IDENTIFIED DID NOT LEAD TO ANY ADVERSE EVENTS. MANUFACTURING PREVENTATIVE ACTIONS HAVE BEEN TAKEN TO STRENGTHEN THE WELD. THE INITIAL IMPORTER, SKYTRON HAS REVIEWED THE FIVE SKYTRON INTEGRITY STEAM STERILIZERS IN THE USA.

    Description of Event or Problem · 1

    THE COMPANY BECAME AWARE OF TWO INCIDENTS OUTSIDE OF THE USA WITH THE STEAM STERILIZER. THE FIRST INCIDENT WAS IN (B)(6) 2017 AND THE SECOND WAS (B)(6) 2017. A WELD ATTACHING THE AIR HEATER/FILTER ASSEMBLY TO THE MAIN STERILIZER UNIT SHOWED SIGNS OF FATIGUE. THE AFFECTED STEAM STERILIZER MODEL IS ONLY AVAILABLE IN (B)(6), HOWEVER THE COMPANY'S US MODEL, SKYTRON INTEGRITY 270, UTILIZES A SIMILAR AIR HEATER/FILTER ASSEMBLY. THE AIR HEATER/FILTER ASSEMBLY SUPPLIES HEATED FRESH AIR INTO THE CHAMBER AFTER THE STERILIZATION AND DRYING PROCESS HAS BEEN COMPLETED. THIS ALLOWS THE CHAMBER TO EQUALIZE TO ATMOSPHERIC PRESSURE PERMITTING THE USER TO OPEN THE CHAMBER AND UNLOAD THE UNITS. IF THERE IS A FAILURE TO THE WELD, THE CHAMBER PRESSURE WOULD STILL EQUALIZE AT THE END OF THE STERILIZATION AND DRYING CYCLE, BUT THE ROOM AIR MAY NOT GO THROUGH THE FILTER. THERE HAS BEEN NO INSTANCES OF FATIGUE OR FAILURE IN THE USA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386641 SKYTRON INTEGRITY 270 STEAM STERILIZER FLE SAKURA SEIKI CO., LTD. CHIKUMA FACTORY ASSR-AO12 10841736100117

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention