BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERRAD 100S STERILIZER

    MDR report key: 1173028 · Received September 19, 2008

    Report

    Report Number
    2084725-2008-00579
    Event Type
    Malfunction
    Date Received
    September 19, 2008
    Date of Event
    August 28, 2008
    Report Date
    August 28, 2008
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    MLR
    PMA / PMN Number
    K991999
    Removal / Correction Number
    Z-0844-2008, 2084725-11/
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: THE ISSUE HAS BEEN ADDRESSED WITH A CUSTOMER LETTER RELATED TO CORRECTIVE & REMOVAL.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT AN ACMI CIRCON UTEROSCOPE AND AN OLYMPUS CYTOSCOPE WERE DAMAGED AFTER BEING PROCESSED IN THE STERRAD 100S. THERE WERE NO USER IMPACT OR ADVERSE EVENT RELATED TO THE DAMAGED DEVICES. ASP CUSTOMER CAN ADVISED THE CUSTOMER THAT THE STERRAD 100S IS NOT VALIDATED TO PROCESS FLEXIBLE INSTRUMENTS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA ACMI CIRCON UTEROSCOPE| OLYMPUS CYTOSCOPE