BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEICA ASP300S

    MDR report key: 7278413 · Received February 16, 2018

    Report

    Report Number
    1423337-2018-00002
    Event Type
    Injury
    Date Received
    February 16, 2018
    Date of Event
    January 19, 2018
    Report Date
    January 19, 2018
    Manufacturer
    LEICA BIOSYSTEMS NUSSLOCH GMBH
    Product Code
    IEO
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2018, LEICA BIOSYSTEMS WAS NOTIFIED THAT THE CUSTOMER EXPERIENCED SUBOPTIMAL TISSUE PROCESSING ON THEIR ASP300S TISSUE PROCESSOR. AS A RESULT, TWO ENDOMETRIAL BIOPSIES WERE UNDIAGNOSABLE. A RE-BIOPSY WAS RECOMMENDED; HOWEVER AS OF (B)(6) 2018, NO INFORMATION HAS BEEN PROVIDED TO LEICA BIOSYSTEMS TO CONFIRM WHETHER THE RE-BIOPSY HAS BEEN PERFORMED. NO RE-BIOPSY SAMPLE HAS BEEN RECEIVED BY THE LAB. A FOLLOW UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    FOLLOWING THE LEICA MANUFACTURER'S INVESTIGATION IT WAS DETERMINED THE INCIDENT WAS RELATED TO A PRESSURE FAILURE OF THE INSTRUMENT. TO DATE, A RE-BIOPSY HAS NOT BEEN PERFORMED. SEE MANUFACTURER'S REPORT NUMBER 8010478-2018-00001 FOLLOW UP #01 FOR ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    119332 LEICA ASP300S ASP300S IEO LEICA BIOSYSTEMS NUSSLOCH GMBH 14047643515

    Patients

    Seq Age Sex Outcome Treatment
    1 Other