BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEICA CM1520

    MDR report key: 6142918 · Received December 2, 2016

    Report

    Report Number
    1423337-2016-00030
    Event Type
    Injury
    Date Received
    December 2, 2016
    Date of Event
    August 3, 2016
    Report Date
    November 8, 2016
    Manufacturer
    LEICA BIOSYSTEMS NUSSLOCH GMBH
    Product Code
    IDP
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON 08 NOVEMBER 2016, LEICA BIOSYSTEMS RECEIVED A USER FACILITY MEDWATCH FORM 3500A FROM THE FDA REGARDING A NECESSARY RE-BIOPSY OF ONE PATIENT. THE CUSTOMER COMPLAINT WAS THAT THE DEVICE WAS CHUNKING INTO THE TISSUE BLOCK DURING CUTTING. UPON RECEIPT OF THIS USER FACILITY MEDWATCH FORM 3500A, LEICA BIOSYSTEMS INITIALLY BECAME AWARE THAT A RE-BIOPSY WAS REQUIRED. FOR MORE INFORMATION PLEASE REFER TO MANUFACTURER REPORT NUMBER 8010478-2016-00006.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    791576 LEICA CM1520 CRYOSTAT IDP LEICA BIOSYSTEMS NUSSLOCH GMBH 149491520US

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other