BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERRAD 100S STERILIZER

    MDR report key: 1672795 · Received May 4, 2010

    Report

    Report Number
    2084725-2010-00150
    Event Type
    Malfunction
    Date Received
    May 4, 2010
    Date of Event
    April 1, 2010
    Report Date
    April 5, 2010
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    MLR
    PMA / PMN Number
    K991999
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 (SERIAL NUMBER (B)(4)) CONFIRMED THAT THE PRODUCT MET ALL SPECIFICATIONS AT THE TIME OF RELEASE. 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. (B)(4). THE DEVICE TRADE NAME AND/OR MODEL NUMBER WAS NOT PROVIDED TO ASP; THEREFORE, IT IS UNCONFIRMED IF THE DEVICE IS RECOMMENDED BY THE DEVICE MANUFACTURER FOR PROCESSING IN THE STERRAD 100S. THE METAL (SILVER) IS NOT RECOMMENDED FOR PROCESSING WITH ANY OF THE STERRAD MODELS BECAUSE THE OXYGEN, PRODUCED FROM THE DECOMPOSITION OF THE HYDROGEN PEROXIDE GAS, WILL REACT WITH THE SILVER. ASP ADVISED THE CUSTOMER THAT DEVICES MADE OF METAL (SILVER) CANNOT BE PROCESSED IN THE STERRAD SYSTEM.

    Additional Manufacturer Narrative · 1

    CONCOMITANT DEVICES: DEVICES FOR CEREBRAL SURGERY (FUJITA MEDICAL INSTRUMENTS CO. LTD, AND MIZIHO CO. LTD, AESCULAP CO. LTD) - SN# AND PN # UNKNOWN FOR ALL THREE MANUFACTURERS. (B)(4): DAMAGED DEVICE. THE PART AND SERIAL NUMBERS FOR THE DAMAGED DEVICES ARE UNKNOWN; THEREFORE, IT IS NOT POSSIBLE TO DETERMINE IF THE DEVICES ARE APPROVED FOR PROCESSING IN THE STERRAD 100S USING THE ASP STERILITY GUIDE. HOWEVER, DEVICES MADE OF METAL CANNOT BE PROCESSED IN THE STERRAD SYSTEM. THE STERRAD 100S USER'S GUIDE WARNS: 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. THE CUSTOMER WAS ADVISED TO CONTACT THE APPLICABLE DEVICE MANUFACTURER IN ORDER TO EVALUATE THE REPORTED DAMAGED DEVICES.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT AFTER A COMPLETED CYCLE IN THE STERRAD 100S, THE TIPS OF SEVEN OF THE TWENTY-TWO MICRO DEVICES USED FOR CEREBRAL SURGERY APPEARED DAMAGED. THE TIPS WERE MADE OF SILVER AND THE METAL BECAME OXIDIZED BY THE H2O2 CAUSING THE TIPS TO TURN BLACK. THE CUSTOMER WAS INFORMED THAT DEVICES MADE OF THIS METAL (SILVER) CANNOT BE PROCESSED IN THE STERRAD SYSTEM. THE AGE AND USAGE OF THE DEVICES IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERRAD 100S STERILIZER STERRAD EQUIPMENT (MLR) MLR ADVANCED STERILIZATION PRODUCTS 094367

    Patients

    Seq Age Sex Outcome Treatment
    1