BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMO SCIENTIFIC TISSUE-LOC HISTOSCREEN

    MDR report key: 7071353 · Received November 30, 2017

    Report

    Report Number
    1831638-2017-00001
    Event Type
    Malfunction
    Date Received
    November 30, 2017
    Date of Event
    February 21, 2017
    Report Date
    August 4, 2017
    Manufacturer
    RICHARD ALLAN SCIENTIFIC
    Product Code
    IDZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERMO SCIENTIFIC¿ TISSUE-LOC¿ HISTOSCREEN¿ CASSETTES ARE USED FOR HANDLING SMALL BIOPSIES AND FRAGILE SPECIMENS. THE UNIQUE DESIGN PROVIDES AN INNER CHAMBER LINED WITH A "SEE-THROUGH" MESH FOR EASY IDENTIFICATION OF SPECIMENS. THEY ELIMINATE THE NEED FOR MESSY SPONGES OR LENS PAPERS. TISSUE-LOC HISTOSCREEN CASSETTES ARE AVAILABLE IN BULK PACKAGING AND IN TUBES INTENDED FOR HIGH THROUGHPUT PRINTING. THE CUSTOMER COMPLAINED THAT THE SCREEN ON THE TISSUE-LOC CASSETTE WAS DEFECTIVE. THIS CAUSED TISSUE TO BE LOST DURING PROCESSING.

    Description of Event or Problem · 1

    THE CUSTOMER CLAIMED THAT THE SCREEN ON THE LID OF THE TISSUE-LOC CASSETTE WAS DEFECTIVE. THIS CAUSED TISSUE TO BE LOST DURING PROCESSING OF THE TISSUE AND THE PATIENT HAD TO BE REBIOPSIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    852358 THERMO SCIENTIFIC TISSUE-LOC HISTOSCREEN THERMO SCIENTIFIC TISSUE-LOC HISTOSCREEN IDZ RICHARD ALLAN SCIENTIFIC C-0250-GR 103710

    Patients

    Seq Age Sex Outcome Treatment
    1 Other