BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEICA ASP6025

    MDR report key: 3885781 · Received June 6, 2014

    Report

    Report Number
    8010478-2014-00008
    Event Type
    Injury
    Date Received
    June 6, 2014
    Date of Event
    May 5, 2014
    Report Date
    May 7, 2014
    Manufacturer
    LEICA BIOSYSTEMS NUSSLOCH GMBH
    Product Code
    IEO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION OF THE INCIDENT IS CURRENTLY UNDERWAY AND A FOLLOW UP WILL BE SUBMITTED SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE FOLLOWING THE INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT AFTER PROCESSING THE TISSUE SAMPLES HAD BEEN SUB-OPTIMALLY PROCESSED. AS A RESULT, SOME SPECIMENS COULD NOT BE DIAGNOSED. A REBIOPSY OF TWO PATIENTS WAS NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332399 LEICA ASP6025 TISSUE PROCESSOR IEO LEICA BIOSYSTEMS NUSSLOCH GMBH ASP6025

    Patients

    Seq Age Sex Outcome Treatment
    1 Other