BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERRAD NX STERILIZER

    MDR report key: 1230838 · Received November 6, 2008

    Report

    Report Number
    2084725-2008-00721
    Event Type
    Malfunction
    Date Received
    November 6, 2008
    Date of Event
    October 8, 2008
    Report Date
    October 8, 2008
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    MLR
    PMA / PMN Number
    K042116
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REFERENCE MDR 2084725-2008-00722.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT TWO UTEROSCOPES HAD WHITE RESIDUE IN THE LUMENS. WITH BOTH SCOPES, THE RESIDUE WAS DISCOVERED DURING A PROCEDURE. IT WAS NOT DETERMINED THAT THERE WAS RESIDUE IN THE CHANNELS UNTIL A GUIDEWIRE WAS PASSED THROUGH THE SCOPE AND THIS WAS DONE WHILE THE SCOPE WAS IN THE USE WITH THE PT. THE CUSTOMER ALLEGES THAT THERE WERE NO COMPLICATIONS FOLLOWING THE SCOPE USE. THE ASP CUSTOMER CARE REVIEWED THE PROPER CLEANING PROCEDURES WITH THE CUSTOMER.

    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 KARL STORZ FLEXEX UTEROSCOPE| SN UNK