MAUDE Adverse Event Report: CANON MEDICAL SYSTEMS CORPORATION CANON; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

Model Number	INFX-8000C/T1
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It is judged that no further corrective action for the system is needed because the cause is user error.The manual 2b308-309en states the following: warning: special care must be taken to prevent interference between persons in the examination room and the units used in combination.If interference occurs, the concerned person may be injured.Special care must also be taken to prevent interference between units used in combination.If interference occurs, the concerned units may be damaged and, in addition, persons near the units may be injured.Take special care to prevent the support unit and the catheterization table from interfering with peripheral units or devices such as contrast medium injectors, monitors, and monitor suspension units.In particular, the lower section of the tabletop of the catheterization table is obstructed from view and therefore great care is required.
Event or Problem Description
On (b)(6) 2026, at a (b)(6) hospital during an examination the doctor tried to move around while avoiding a large monitor which was on the ceiling suspension stand.However, he stood up before he could completely avoid the monitor, causing the top of the doctor's head to collide with the corner of the monitor.This resulted in a laceration on the top right side of the doctor's head, that required stitches.

• Brand Name: CANON
• Common Device Name: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• 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 ; 7146697459
• MDR Report Key: 24594951
• Report Number: 2020563-2026-00002
• Device Sequence Number: 9158230
• Product Code: OWB
• UDI-Device Identifier: 04987670100192
• UDI-Public: (01)04987670100192
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/13/2026

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 Model Number: INFX-8000C/T1
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2026
• Initial Report FDA Received Date: 03/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male