BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEICA ASP6025

    MDR report key: 4996469 · Received August 10, 2015

    Report

    Report Number
    8010478-2015-00003
    Event Type
    Malfunction
    Date Received
    August 10, 2015
    Date of Event
    July 2, 2015
    Report Date
    July 10, 2015
    Manufacturer
    LEICA BIOSYSTEMS NUSSLOCH GMBH
    Product Code
    IEO
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SAFETY CORRECTIVE ACTION HAS BEEN INITIATED BY THE MANUFACTURER. LEICA BIOSYSTEMS IS ISSUING THE FIELD SAFETY NOTICE (FSN) TO INFORM THE CUSTOMER ABOUT A FIELD SAFETY CORRECTIVE ACTION (FSCA) THAT WE ARE INITIATING, TO ADDRESS AN ISSUE WE HAVE EXPERIENCED WITH OUR TISSUE PROCESSOR, (B)(4).

    Description of Event or Problem · 1

    THE (B)(4) IS SPORADICALLY AND INCORRECTLY GETTING INTO THE WRONG INSTRUMENT STATE "BOTTLE EMPTY" DURING RETORT FILLING. THIS POTENTIALLY LEADS TO SUBOPTIMAL QUALITY OF PROCESSED TISSUE. IN SOME CASES, A RE-BIOPSY OF THE PATIENT COULD BE NECESSARY IN ORDER TO OBTAIN ANOTHER VIABLE TISSUE SAMPLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    522905 LEICA ASP6025 AUTOMATED TISSUE PROCESSOR IEO LEICA BIOSYSTEMS NUSSLOCH GMBH 14049543267

    Patients

    Seq Age Sex Outcome Treatment
    1