BEUDAMED
    FDA Adverse Event Other Summary report: N

    LOW TEMPERATURE STERILIZERS

    MDR report key: 648795 · Received December 2, 2005

    Report

    Report Number
    1527821-2005-00004
    Event Type
    Other
    Date Received
    December 2, 2005
    Date of Event
    August 1, 2004
    Report Date
    December 2, 2005
    Manufacturer
    STERIS CORPORATION
    Product Code
    FLE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NO INFORMATION

    Narratives

    Description of Event or Problem · 1

    STERIS RECEIVED A REPORT THROUGH ITS COMPLAINT SYSTEM IN 2005 THAT A CUSTOMER HAD BEEN ATTEMPTING TO PROCESS AN OLYMPUS GASTROSCOPE (MODEL GIF-1TQ160) IN SYSTEM 1. HOWEVER, STERIS HAS NOT VALIDATED A QUICK CONNECT FOR USE WITH THIS MODEL SCOPE IN SYSTEM 1, AND THEREFORE DOES NOT LABEL FOR THE DEVICE. ACCORDING TO A BIOMEDICAL TECHNICIAN AT THE FACILITY, THE HOSP HAD BEEN ATTEMPTING TO PROCESS THE DEVICE IN SYSTEM 1 USING ONE OF TWO QUICK CONNECTS PREVIOUSLY PURCHASED FROM STERIS (QLC1629 AND QLC1689), BUT WHICH ARE NOT LABELED FOR THE DEVICE. THE CUSTOMER LATER INDICATED THAT APPROXIMATELY 230 PTS MAY HAVE BEEN INVOLVED. STERIS HAS OFFERED ITS ASSISTANCE TO THE FACILITY BY WAY OF TRAINING AND EVALUATION OF THE FACILITY'S SCOPE INVENTORY TO ENSURE THAT PROPER QUICK CONNECTS (WHERE APPROPRIATE) AND PRACTICES ARE BEING UTILIZED, BUT TO DATE THE FACILITY HAS NOT PERMITTED STERIS TO ASSIST IN THIS MANNER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LOW TEMPERATURE STERILIZERS * FLE STERIS CORPORATION 4031717 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other