MAUDE Adverse Event Report: FUJIFILM CORPORATION ASPIRE CRISTALLE; FDR MS-3500

Model Number	DR 3500 W 24X30 USA E
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Bruise/Contusion (1754)
Date of Event	09/28/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The customer understands that this issue was caused by human error and the single-touch should not have been used with the biopsy chair and patient near the gantry, per the warning written in the reference manual (897n120115f).Per the reference manual, "make sure that no obstacle is placed within the operation range of the swivel arm before using the single-touch function.Make sure that no one is around the equipment before using the single-touch button." there was no malfunction associated with the device.This report is being submitted in abundance of caution.The on-site customer service engineer (cse) was dispatched to the customer site.The device was inspected and calibrated, then returned to service.If there is any additional relevant information provided a supplemental report will be submitted.
Event or Problem Description
It was reported that an injury occurred during an exam being performed with an aspire cristalle.The patient with multiple sclerosis who was an invalid and could not use their hands was seated in a biopsy chair.The primary mammographer pressed the "one touch" button to move the gantry to the home position, at this time the assisting mammographer had their hand between the chair and the moving tube arm.The moving tube arm hit the chair and the assisting mammographer's hand in between; the tube arm bended when it hit the chair and assisting mammographer.The assisting mammographer continued working until the next day, however then the mammographer (assisting) started feeling pain and went to urgent care; the hand was black and blue.After further follow up with the assisting mammographer, it was found that an x-ray was performed for the injured hand and there were no bone breaks; several days later the bruising went down and the hand was back to normal.There was no malfunction of the device.There was no adverse event or injury to the primary mammographer or the patient.No other information was provided.

• Brand Name: ASPIRE CRISTALLE
• Common Device Name: FDR MS-3500
• Manufacturer (Section D): FUJIFILM CORPORATION; 798 miyanodai kaisei-machi; ashigarakami-gun, kanagawa 258-8 538; JA 258-8538
• MDR Report Key: 8046224
• Report Number: 2443168-2018-00001
• Device Sequence Number: 16540646
• Product Code: MUE
• UDI-Device Identifier: 04547410297546
• UDI-Public: (01)04547410297546
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/07/2018
• Report Date (Section F): 11/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: DR 3500 W 24X30 USA E
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/15/2018
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 11/07/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1