MAUDE Adverse Event Report: FUJIFILM CORPORATION ASPIRE CRISTALLE DIGITAL BREAST TOMOSYNTHESIS OPTION; DIGITAL BREAST TOMOSYNTHESIS MAMMOGRAPHY SYSTEM

Model Number	FDR MS-3500
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If any additional relevant information becomes available, a supplemental report will be submitted.
Event or Problem Description
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.
Additional Manufacturer Narrative
Correction: initial manufacturer report was submitted with 30 jan 2019, but it should have been 23 feb 2019.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.If any additional relevant information becomes available, a supplemental report will be submitted.
Event or Problem Description
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.

• Brand Name: ASPIRE CRISTALLE DIGITAL BREAST TOMOSYNTHESIS OPTION
• Common Device Name: DIGITAL BREAST TOMOSYNTHESIS MAMMOGRAPHY SYSTEM
• Manufacturer (Section D): FUJIFILM CORPORATION; 798 miyanodai kaisei-machi; ashigarakami-gun, kanagawa 00258 8538; JA 002588538
• MDR Report Key: 8378399
• Report Number: 3001722928-2019-00001
• Device Sequence Number: 11120911
• Product Code: OTE
• UDI-Device Identifier: 04547410297546
• UDI-Public: 04547410297546
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: P160031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: FDR MS-3500
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/30/2019
• Supplement Date Received by Manufacturer: 02/23/2019
• Initial Report FDA Received Date: 02/28/2019
• Supplement Report FDA Received Date: 05/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1