MAUDE Adverse Event Report: FUJIFILM CORPORATION FDR D-EVO II FLAT PANEL DETECTOR SYSTEM; SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)

Model Number	DR-ID1200
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Damage to Ligament(s) (1952)
Date of Event	02/07/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2023, fujifilm healthcare americas corporation became aware of an event involving fdr d-evo ii panel.It was reported that a technician tripped over the power cable and fell, tearing the ulnar collateral ligament in her right thumb.The technician was triaged in the emergency room following the incident and was informed that surgery will be required to repair the tear.The technician was released from the emergency room in stable condition.There is no death reported with the event.

• Brand Name: FDR D-EVO II FLAT PANEL DETECTOR SYSTEM
• Common Device Name: SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)
• Manufacturer (Section D): FUJIFILM CORPORATION; 798 miyanodai kaisei-machi; ashigarakami-gun, kanagawa 258-8 538; JA 258-8538
• MDR Report Key: 16466333
• Report Number: 1000513161-2023-00005
• Device Sequence Number: 12045417
• Product Code: MQB
• UDI-Device Identifier: 04547410309294
• UDI-Public: (01)04547410309294(11)210201
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/02/2023

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-ID1200
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/07/2023
• Device Age: 2 YR
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/02/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 31 YR
• Patient Sex: Female