BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TISSUE-TEK UNI CASSETTE

    MDR report key: 1668370 · Received April 14, 2010

    Report

    Report Number
    2083544-2010-00002
    Event Type
    Malfunction
    Date Received
    April 14, 2010
    Date of Event
    February 26, 2010
    Report Date
    March 24, 2010
    Manufacturer
    SAKURA FINETEK USA, INC.
    Product Code
    IDZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW AND EVALUATE PROCESSING AND QUALITY CONTROL PROCEDURES OF THE CASSETTE MANUFACTURER TO ENSURE ADEQUATE QUALITY CONTROL LEVELS FOR IN-PROCESS INSPECTION OF CASSETTES.

    Description of Event or Problem · 1

    ANATOMIC PATHOLOGY TISSUE CASSETTE LID CLOSED INCOMPLETELY OR LOOSENED DURING TISSUE PROCESSING. THE DEFECTIVE CASSETTES WERE NOT DETECTED IMMEDIATELY THROUGH THE NORMAL QUALITY CONTROL PROCEDURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TISSUE-TEK UNI CASSETTE UNI-CASSETTE IDZ SAKURA FINETEK USA, INC. 433673

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention