BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STERRAD NX STERILIZER

    MDR report key: 1210745 · Received October 23, 2008

    Report

    Report Number
    2084725-2008-00696
    Event Type
    Injury
    Date Received
    October 23, 2008
    Date of Event
    September 24, 2008
    Report Date
    September 24, 2008
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    MLR
    PMA / PMN Number
    K042116
    Removal / Correction Number
    Z-1631-2008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESPIRATORY EMBARRASSMENT, BURNS ON THE LEVEL OF THE THROAT, IRRITATED EYES. OIL MIST. CAPITAL EQUIPMENT, EVALUATED AT CUSTOMER SITE. THE FSE PERFORMED THE FOLLOWING CHECKS AND TESTS: OIL LEVEL IN THE VACUUM PUMP, LEAK OF THE CHAMBER AND OIL FILTER AND VALVE. THREE EMPTY CYCLES WERE RUN WITHOUT WHITE SMOKE FROM OUTPUT OF THE OIL FILTER. THERE WAS NO WHITE SMOKE NOR SMELL. AS A CAUTION MEASURE, REPLACEMENT OF THE OIL FILTER. REFERENCE MDRS: 2084725-2008-00694, 00695, 00697, 00698, 00699, 00700, 00701, 00702 AND 00703.

    Description of Event or Problem · 1

    THE AFFILIATES REPORTED THAT THE CUSTOMER EXPERIENCED THE LOW AREA H2O2 CANCELLATION. THE CUSTOMER EDITED CYCLE TICKET, OPENED MACHINE DOOR, AND BROUGHT THE LOAD FROM THE STERILIZATION ROOM TO THE WASHING ROOM. THE CUSTOMER DID NOT MENTION THE PRESENCE OF SMOKE OR SMELL IN THE STERILIZATION ROOM WHEN OPENING THE DOOR MACHINE TO TAKE THE LOAD. ONE OR TWO MINUTES LATER, THE CUSTOMER NOTICED A SMELL IN THE STERILIZATION ROOM. THEY ALSO NOTICED A WHITE SMOKE IN THE WASHING ROOM BUT NOT IN THE STERILIZATION ROOM. THE CUSTOMER CONFIRMED THAT THEY DID NOT MODIFY WASHING PROCEDURE FOR CYSTOSCOPE NOR CHANGE DETERGENT. THE CUSTOMER REPORTED TEN EXPERIENCED "RESPIRATORY EMBARRASSMENT, BURNS ON THE LEVELS OF THROAT, HEADACHE AND EYE IRRITATION." ONE OF THE TEN PEOPLE WENT TO THE OPHTHALMOLOGIST FOR PERSISTENT EYE IRRITATION. THE OTHER NINE DID NOT SEEK MEDICAL ATTENTION OR REQUIRE TREATMENT. IT WAS ALSO REPORTED THAT AFTER FIVE DAYS, THE SYMPTOMS OF THE TEN PEOPLE HAVE RESOLVED. THE FIELD SERVICE ENGINEER WENT TO THE FACILITY TO ASSESS THE UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERRAD NX STERILIZER STERRAD EQUIPMENT (MLR) MLR ADVANCED STERILIZATION PRODUCTS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK STERRAD CASSETTE