BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERRAD 100S STERILIZER

    MDR report key: 1656502 · Received April 12, 2010

    Report

    Report Number
    2084725-2010-00119
    Event Type
    Malfunction
    Date Received
    April 12, 2010
    Date of Event
    March 1, 2010
    Report Date
    March 18, 2010
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    MLR
    PMA / PMN Number
    K991999
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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 100S SYSTEM (SN: (B)(4)) WAS REVIEWED AND THERE WERE NO ISSUES NOTED. THE SERVICE AND COMPLAINT HISTORY FOR THE STERRAD 100S DID NOT REVEAL A TREND FOR DAMAGE TO CUSTOMER DEVICE. TRENDING ANALYSIS FOR DAMAGE TO CUSTOMER DEVICE ISSUES ASSOCIATED TO THE STERRAD 100S DID NOT INDICATE A SIGNIFICANT TREND. TRENDING ANALYSIS FOR FOREIGN MATTER ISSUES ASSOCIATED TO THE STERRAD 100S FOUND THREE COMPLAINTS TOTAL. (B)(4). THE PROBE MANUFACTURER CONFIRMED THAT THE PROBE WAS RECOMMENDED FOR STERRAD 100S PROCESSING. TOSHIBA REPLACED THE DAMAGED PROBES. THE REPAIR REPORT WAS NOT PROVIDED TO ASP. WITHOUT THE REPAIR REPORT THE ROOT CAUSE OF THE PROBE DAMAGE REMAINS UNKNOWN.

    Additional Manufacturer Narrative · 1

    (B)(4): DAMAGED DEVICE. PER STERRAD 100S USER'S GUIDE: KNOW WHAT YOU CAN PROCESS: BEFORE PROCESSING ANY ITEM IN THE STERRAD 100S STERILIZER, MAKE SURE YOU KNOW HOW THE STERRAD STERILIZATION PROCESS WILL AFFECT THE ITEM. READ, UNDERSTAND, AND FOLLOW THE MEDICAL DEVICE MANUFACTURERS' INSTRUCTIONS FOR THEIR PRODUCTS. THE FOLDOUT CHART IN THIS GUIDE LISTS THE CERTAIN TYPES OF ITEMS AND MATERIALS THAT CAN BE SAFELY PROCESSED IN THE STERILIZER. THIS GUIDE IS NOT INTENDED TO REPLACE ANY MEDICAL DEVICE MANUFACTURERS' INSTRUCTIONS. IF YOU HAVE QUESTIONS, OR IF YOU ARE IN DOUBT ABOUT THE MATERIALS IN YOUR DEVICES, CONTACT THE MEDICAL DEVICE MANUFACTURER OR YOUR ASP CUSTOMER REPRESENTATIVE FOR MORE INFORMATION.

    Description of Event or Problem · 1

    A CUSTOMER ALLEGED A LIQUID SUBSTANCE SEEPING OUT OF A 7-8 YEAR OLD TOSHIBA U/S IVF VAGINAL PROBE. IT WAS REPORTED THAT THE INSIDE OF THE PROBE HAS SOME COPPER ELEMENT BUT IS SEALED INSIDE SILICONE. THERE IS A RUSTY COLORED LIQUID LEAKING FROM THE PROBE HANDLE. TOSHIBA HAS VALIDATED THIS PROBE FOR RE-STERILIZING THROUGH STERRAD 100S. THE MANUFACTURER OF THE PROBE HAS BEEN NOTIFIED AND IS CONDUCTING AN INVESTIGATION. THE INVESTIGATION RESULTS FROM THE PROBE MANUFACTURER WILL BE REPORTED ON A SUPPLEMENTAL REPORT IF RECEIVED BY ASP.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 TOSHIBA U/S IVF VAGINAL PROBE