BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEICA ASP6025

    MDR report key: 2850274 · Received November 26, 2012

    Report

    Report Number
    8010478-2012-00006
    Event Type
    Malfunction
    Date Received
    November 26, 2012
    Date of Event
    October 29, 2012
    Report Date
    October 29, 2012
    Manufacturer
    LEICA BIOSYSTEMS NUSSLOCH GMBH
    Product Code
    IEO
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A RECALL HAS BEEN INITIATED AND THE INSTRUMENT MUST BE RETURNED FOR AN INVESTIGATION TO THE MANUFACTURER.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT AFTER PROCESSING THE TISSUES WERE SUBOPTIMAL PROCESSED. AS A RESULT, SOME SPECIMENS COULD NOT BE DIAGNOSED, BUT NO PATIENT REQUIRED RE-BIOPSY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEICA ASP6025 TISSUE PROCESOR IEO LEICA BIOSYSTEMS NUSSLOCH GMBH ASP6025

    Patients

    Seq Age Sex Outcome Treatment
    1