BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASPIRE CRISTALLE DIGITAL BREAST TOMOSYNTHESIS OPTION

    MDR report key: 8378403 · Received February 28, 2019

    Report

    Report Number
    1000513161-2019-00001
    Event Type
    Malfunction
    Date Received
    February 28, 2019
    Date of Event
    January 30, 2019
    Report Date
    May 7, 2019
    Manufacturer
    FUJIFILM CORPORATION
    Product Code
    OTE
    UDI-DI
    04547410297546
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: FURTHER REVIEW BY A THIRD-PARTY INDEPENDENT ASSESSMENT ON 09 APR 2019 CONFIRMED THAT THERE WAS NO DEVICE MALFUNCTION ASSOCIATED WITH THIS COMPLAINT.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTS THAT SCREENINGS CONDUCTED WITH THE ASPIRE CRISTALLE DIGITAL BREAST TOMOSYNTHESIS (DBT) OPTION MAY BE GENERATING LOWER PATIENT RECALL RATES AT THEIR HEALTHCARE FACILITY THAN EXPECTED. WHILE THE ASPIRE CRISTALLE PRODUCT IS FUNCTIONING TO SPECIFICATIONS, FURTHER REVIEW IS BEING CONDUCTED. THERE IS NO KNOWN DEATH OR SERIOUS INJURY ASSOCIATED WITH THIS EVENT. THIS EVENT IS BEING REPORTED IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS THAT SCREENINGS CONDUCTED WITH THE ASPIRE CRISTALLE DIGITAL BREAST TOMOSYNTHESIS (DBT) OPTION MAY BE GENERATING LOWER PATIENT RECALL RATES AT THEIR HEALTHCARE FACILITY THAN EXPECTED. WHILE THE ASPIRE CRISTALLE PRODUCT IS FUNCTIONING TO SPECIFICATIONS, FURTHER REVIEW IS BEING CONDUCTED. THERE IS NO KNOWN DEATH OR SERIOUS INJURY ASSOCIATED WITH THIS EVENT. THIS EVENT IS BEING REPORTED IN AN ABUNDANCE OF CAUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171832 ASPIRE CRISTALLE DIGITAL BREAST TOMOSYNTHESIS OPTION DIGITAL BREAST TOMOSYNTHESIS MAMMOGRAPHY SYSTEM OTE FUJIFILM CORPORATION FDR MS-3500 N/A 04547410297546

    Patients

    Seq Age Sex Outcome Treatment
    1