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

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Damage to Ligament(s) (1952)

Event Date 02/07/2023

Event Type  Injury  

Event 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
• Type of Device: 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
• MDR Text Key: 310493255
• Report Number: 1000513161-2023-00005
• Device Sequence Number: 1
• Product Code: MQB
• UDI-Device Identifier: 04547410309294
• UDI-Public: (01)04547410309294(11)210201
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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 Manufacturer Received: Not provided
• Initial Date FDA Received: 03/02/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 31 YR
• Patient Sex: Female