BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASPIRE CRISTALLE

    MDR report key: 8775970 · Received July 10, 2019

    Report

    Report Number
    3001722928-2019-00008
    Event Type
    Injury
    Date Received
    July 10, 2019
    Date of Event
    June 17, 2019
    Report Date
    October 30, 2019
    Manufacturer
    FUJIFILM CORPORATION
    Product Code
    OTE
    UDI-DI
    04574102975456
    PMA / PMN Number
    P160031
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AN INDEPENDENT ASSESSMENT WAS PERFORMED BY A BOARD CERTIFIED RADIOLOGIST. THE INDEPENDENT ASSESSMENT CONCLUDED THAT IN ALL THREE (3) PATIENT CASES THE QUALITY OF THE IMAGES PRODUCED ON THE ASPIRE CRISTALLE WERE FIT FOR USE AS PART OF A DIAGNOSTIC MAMMOGRAPHY EXAMINATION. IF ANY ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    SELF REGIONAL HOSPITAL INFORMED FUJIFILM MEDICAL SYSTEM, U.S.A, INC. ON JUNE 17, 2019 THAT THEY HAD RECALLED APPROXIMATELY 300 PATIENTS THAT HAD BEEN EXAMINED USING THE FUJIFILM ASPIRE CRISTALLE PRODUCT (NOVEMBER 2018, DECEMBER 2018, AND JANUARY 2019) AND THEY HAVE IDENTIFIED THREE (3) PATIENT CASES WHERE AN EARLY STAGE OF BREAST CANCER WAS DETECTED BASED ON BIOPSIES CONDUCTED AFTER THE PATIENTS WERE RE-SCREENED USING NON-FUJIFILM MAMMOGRAPHY EQUIPMENT. A COMPLAINT FOR A POTENTIAL ISSUE AT THIS CUSTOMER FACILITY WAS PREVIOUSLY REPORTED UNDER 3001722928-2019-00001 AND 1000513161-2019-00001

    Additional Manufacturer Narrative · 1

    IF ANY ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    (B)(6) REGIONAL HOSPITAL INFORMED FUJIFILM MEDICAL SYSTEM, U.S.A, INC. ON (B)(6) 2019 THAT THEY HAD RECALLED APPROXIMATELY 300 PATIENTS THAT HAD BEEN EXAMINED USING THE FUJIFILM ASPIRE CRISTALLE PRODUCT ((B)(6) 2018, (B)(6) 2018, AND (B)(6) 2019) AND THEY HAVE IDENTIFIED THREE (3) PATIENT CASES WHERE AN EARLY STAGE OF BREAST CANCER WAS DETECTED BASED ON BIOPSIES CONDUCTED AFTER THE PATIENTS WERE RE-SCREENED USING NON-FUJIFILM MAMMOGRAPHY EQUIPMENT. A COMPLAINT FOR A POTENTIAL ISSUE AT THIS CUSTOMER FACILITY WAS PREVIOUSLY REPORTED UNDER 3001722928-2019-00001 AND 1000513161-2019-00001.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    572187 ASPIRE CRISTALLE DIGITAL BREAST TOMOSYNTHESIS MAMMOGRAPHY SYSTEM OTE FUJIFILM CORPORATION FDR MS-3500 N/A 04574102975456

    Patients

    Seq Age Sex Outcome Treatment
    1 Other