BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERRAD NX STERILIZATION SYSTEM

    MDR report key: 921514 · Received October 2, 2007

    Report

    Report Number
    2084725-2007-00299
    Event Type
    Malfunction
    Date Received
    October 2, 2007
    Date of Event
    September 4, 2007
    Report Date
    September 4, 2007
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    MLR
    PMA / PMN Number
    K042116
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A LENS COMING OUT OF A SCOPE. THE CUSTOMER STATED THAT THE LENS WAS NOTICED MISSING BEFORE THE SCOPE WAS INTRODUCED IN TO THE PATIENT. THE SMITH & NEPHEW DYONICS SCOPE IS NOT COMPATIBLE WITH THE STERRAD NX. THE CUSTOMER IS AWARE THAT THE SCOPE IS NOT COMPATIBLE WITH THE UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERRAD NX STERILIZATION SYSTEM STERILIZER MLR ADVANCED STERILIZATION PRODUCTS 10033 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 YR