BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERRAD 100S STERILIZER

    MDR report key: 1603996 · Received February 1, 2010

    Report

    Report Number
    2084725-2010-00033
    Event Type
    Malfunction
    Date Received
    February 1, 2010
    Date of Event
    February 28, 2009
    Report Date
    January 8, 2010
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    MLR
    PMA / PMN Number
    K991999
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ASP INVESTIGATION ANALYSIS: THE DAMAGED DEVICE WAS NOT RETURNED TO ASP. THE SERVICE REQUESTS FOR THE STERRAD 100S UNIT SHOWED NO OTHER DAMAGED DEVICE COMPLAINT AS OF (B)(4) 2010. THE STERRAD 100S DPMO (DEFECTS PER MILLION OPPORTUNITIES) CHART, WITH THE PROBLEM CODE "DAMAGE TO CUSTOMER DEVICE," OVER THE LAST 12 MONTHS (06/2009 TO 06/2010) SHOWED THAT THERE WAS NO INCREASING TREND AND WAS BELOW THE UPPER CONTROL LIMIT (UCL). THE DEVICE HISTORY RECORD (DHR) FOR THE STERRAD 100S UNIT WAS REVIEWED AND THERE WERE NO ISSUES NOTED. PER THE STERRAD FAMILY SHUMA (SYSTEM HAZARD USER MISUSE ANALYSIS) THE RISK OF THIS ISSUE IS ACCEPTABLE. PER THE STRYKER'S INSTRUCTIONS, THE STRYKER LIGHT CORD WAS RECOMMENDED FOR PROCESSING IN THE STERRAD 100S BUT SHOULD NOT HAVE BEEN PLACED IN STERILIZATION POUCHES FOR STERILIZATION. THE MANUFACTURER'S INSTRUCTIONS, DOCUMENT 233-065-077, REV. G, TITLED, "STRYKER FIBEROPTIC CABLES MAINTENANCE AND STERILIZATION" PG. 2 OF 2, UNDER THE "STERILIZATION" HEADING, UNDER THE "STERRAD" SUBCATEGORY, STATE, "USE THE MANUFACTURER'S INSTRUCTIONS FOR OPERATION. DO NOT STERILIZE IN STERILIZATION POUCHES. DOING SO MAY RESULT IN DAMAGE TO THE DEVICE."

    Additional Manufacturer Narrative · 1

    (B)(4): DAMAGED DEVICE, (B)(4).

    Description of Event or Problem · 1

    A STRYKER LIGHT CORD WAS PROCESSED IN A TYVEK POUCH OVER A YEAR AGO, AND STORED IN THE OPERATING ROOM. WHEN THE STAFF REMOVED THE LIGHT CORD, IT WAS FOUND THAT A PORTION WAS MELTED AND UNABLE TO BE USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERRAD 100S STERILIZER STERRAD EQUIPMENT (MLR) MLR ADVANCED STERILIZATION PRODUCTS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA STPOUCH LOT# UNK| STRYKER LIGHT CORD