BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERRAD NX STERILIZER

    MDR report key: 1231079 · Received October 30, 2008

    Report

    Report Number
    2084725-2008-00705
    Event Type
    Malfunction
    Date Received
    October 30, 2008
    Date of Event
    October 9, 2008
    Report Date
    October 9, 2008
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    MLR
    PMA / PMN Number
    K042116
    Removal / Correction Number
    Z-0844-2008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DAMAGED DEVICE, CONCLUSION: THE REPORTED ISSUE HAS BEEN DOCUMENTED INTO ASP'S COMPLAINT SYSTEM FOR TRACKING AND TRENDING PURPOSES. AS MANUFACTURERS INTRODUCE NEW TECHNOLOGIES AND MAKE MATERIALS, MFG AND REPAIR PROCESS CHANGED TO THEIR DEVICES, ASP DOES NOT HAVE THE MEANS TO PROVIDED UP-TO-DATE INFO RELATED TO SPECIFIC BRANDS AND MODELS OF MEDICAL DEVICES THAT MAY BE PROCESSED IN THE STERRAD SYSTEMS. ASP MAY WORK WITH SPECIFIC DEVICE MANUFACTURERS TO TEST FOR COMPATIBILITY IN THE STERRAD SYSTEMS, HOWEVER, THE COMPATIBILITY DATA AND THE DECISION AS TO WHETHER THE DEVICE IS COMPATIBLE IN THE STERRAD SYSTEMS IS ULTIMATELY THE DECISION OF THE DEVICE MFR. IN 2007, A CAPA WAS INITIATED AND CUSTOMER LETTER WAS SENT TO ALL STERRAD SYSTEMS USERS TO DIRECTLY CONTACT THE DEVICE MFR REGARDING MATERIAL COMPATIBILITY AND FUNCTIONAL PERFORMANCE QUESTIONS OF THE DEVICE WITH THE STERRAD SYSTEMS. ASP WILL CONTINUE TO TRACK AND TREND.

    Description of Event or Problem · 1

    AN ASP ACCOUNT EXECUTIVE REPORTED THAT HE HAD A CUSTOMER WHO PROCESSED A RIGID ACMI SCOPE ON THE ADVANCED CYCLE INSTEAD OF THE STANDARD AND THE BLACK PART OF THE EYEPIECE BUBBLED. THE CUSTOMER INVESTIGATED THE DAMAGED SCOPE AND IT WAS DETERMINED THAT THE MR 6 SCOPE HAS A DUAL LUMEN. THERE WERE NO REPORTS OF ANY INJURY TO A PT OR A HEALTHCARE WORKER.

    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 NA ACMI SHORT RIGID UTEROSCOPE