BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERIS RELIANCE 6000

    MDR report key: 9592545 · Received January 14, 2020

    Report

    Report Number
    MW5092247
    Event Type
    Malfunction
    Date Received
    January 14, 2020
    Date of Event
    January 2, 2020
    Report Date
    January 10, 2020
    Manufacturer
    STERIS CANADA ULC
    Product Code
    JRJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    STERIS RELIANCE 6000 ENDOSCOPE DRYING CABINET TUBING SETS STERILIZED FOLLOWING THE IFU FROM THE MFR BECAME MELTED WITH SMALL PIECES OF HARD CLEAR PLASTIC BREAKING OFF AND PRESENT THROUGHOUT THE TUBING AFTER STERILIZING. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    52143 STERIS RELIANCE 6000 UNIT, DRYING JRJ STERIS CANADA ULC RECT1CON20

    Patients

    Seq Age Sex Outcome Treatment
    1