MAUDE Adverse Event Report: CANON MEDICAL SYSTEMS CORPORATION CANON; System, x-ray, fluoroscopic, image-intensified

Model Number	DREX-UI80/05
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The c-arm was tilted and positioned so that the x-ray tube side was in front of the table.The nurse didn't notice the tilted c-arm and accidentally bumped into it while moving around the table.At that time, the c-arm and the table were stopped.
Event or Problem Description
On (b)(6) 2025, a nurse accidentally bumped into the c-arm of the device and received a cut on her face between her eyebrows.She received stitches as medical treatment for the cut.

• Brand Name: CANON
• Common Device Name: System, x-ray, fluoroscopic, image-intensified
• Manufacturer (Section D): CANON MEDICAL SYSTEMS CORPORATION; 1385 shimoishigami; otawara-shi, tochigi 324-8 550; JA 324-8550
• Manufacturer (Section G): CANON MEDICAL SYSTEMS CORPORATION; 1385 shimoishigami; otawara-shi, tochigi 324-8 550; JA 324-8550
• Manufacturer Contact: orlando tadeo ; 2441 michelle drive; tustin,, CA 92780 ; 7146697808
• MDR Report Key: 22736472
• Report Number: 2020563-2025-00007
• Device Sequence Number: 15253497
• Product Code: JAA
• UDI-Device Identifier: 04987670100147
• UDI-Public: 04987670100147
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial

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: DREX-UI80/05
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/06/2025
• Initial Report FDA Received Date: 08/07/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female