BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERRAD NX STERILIZER

    MDR report key: 1626618 · Received February 12, 2010

    Report

    Report Number
    2084725-2010-00041
    Event Type
    Malfunction
    Date Received
    February 12, 2010
    Date of Event
    January 18, 2010
    Report Date
    January 18, 2010
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    MLR
    PMA / PMN Number
    K042116
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ASP INVESTIGATION SUMMARY: THE INVESTIGATION INCLUDED A REVIEW OF THE DEVICE HISTORY, THE SERVICE AND COMPLAINT HISTORY, TRENDING BY PRODUCT LINE AND SYSTEM SERIAL NUMBER AND THE SYSTEM HAZARD AND USER MISUSE ANALYSIS. THE DHR (DEVICE HISTORY REVIEW) FOR THE STERRAD NX SYSTEM ((B)(4)) CONFIRMED THAT THE PRODUCT MET ALL SPECIFICATIONS AT THE TIME OF RELEASE. THE SERVICE AND COMPLAINT HISTORY FOR THE STERRAD NX DID NOT REVEAL A TREND FOR DAMAGE TO CUSTOMER DEVICE TRENDING ANALYSIS FOR DAMAGE TO CUSTOMER DEVICE ISSUES ASSOCIATED TO THE STERRAD NX DID NOT INDICATE A SIGNIFICANT TREND. THE SHUMA (SYSTEM HAZARD AND USER MISUSE ANALYSIS) IS REPORTED TO BE A SCORE OF 4 OR "BROADLY ACCEPTABLE RISK". THE CUSTOMER STATED THERE WAS A WHITE MARKING ON THE SCOPE. THE MEDICAL DEVICE MANUFACTURER (MDM) CONFIRMED THAT IF THERE WAS A WHITE MARKING ON THE SCOPE, IT WAS OKAY FOR PROCESSING IN THE STERRAD NX. A LETTER FROM THE MANUFACTURER (B)(4), DATED (B)(4), 2010 STATES, "OLYMPUS FLEXIBLE ENDOSCOPES THAT ARE COMPATIBLE WITH THE STERRAD NX ARE IDENTIFIED BY THE PRESENCE OF A WHITE LINE ON THE CONTROL SECTION. OLYMPUS FLEXIBLE ENDOSCOPES THAT DO NOT CONTAIN THE IDENTIFYING WHITE LINE ARE NOT COMPATIBLE WITH STERRAD NX." THE SCOPE MODEL # CYF-5 IS LISTED AS ONE OF THE QUALIFYING SCOPES. THOSE RECOMMENDED SCOPES WERE RELEASED INTO THE MARKET IN LATE 2009. THE MDM STATED THE SCOPE WAS RECOMMENDED FOR PROCESSING IN THE STERRAD NX (B)(4). ACCORDING TO THE MDM, THE CUSTOMER RETURNED THE SCOPE FOR REPAIR. THE MDM CONFIRMED THAT THE SCOPE HAD BLISTERING. THE OTHER DAMAGES WERE TO THE SCOPE'S UD PLATE AND DIOPTER. ACCORDING TO THE CUSTOMER, THE MDM REPRESENTATIVE LOOKED AT THE SCOPE AND DISCUSSED THE BUBBLING WITH OTHERS FROM THE COMPANY. THE MDM FELT THE BUBBLING WAS THE RESULT OF THE STERRAD NX PROCESSING. THE CUSTOMER DID NOT RETURN THE SCOPE AND CONTINUED TO USE IT WITH NO FURTHER PROBLEMS. SINCE THE CUSTOMER'S SCOPE WAS RECOMMENDED FOR PROCESSING IN THE STERRAD NX, THE CUSTOMER HAD NO FURTHER PROBLEMS WITH THE SCOPE AFTER THIS INCIDENT, AND THE ASP FSE FOUND THE STERRAD NX UNIT MEETING SPECIFICATION ON (B)(4) 201 (AFTER THE (B)(4) 2010 EVENT). THE ROOT CAUSE OF THE DAMAGES WAS INCONCLUSIVE.

    Description of Event or Problem · 1

    CUSTOMER STATES THAT SHE PROCESSED AN OLYMPUS SCOPE FOR THE FIRST TIME AND THE PAINT ON THE SCOPE IS BUBBLING AND CHIPPING. THE CUSTOMER STATES THIS IS A BRAND NEW SCOPE AND THIS IS THE FIRST TIME SHE PROCESSED THIS SCOPE IN THE STERRAD.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other