MAUDE Adverse Event Report: CANON INC. CANON; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

Model Number	INFX-8000V
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/02/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
In this case, the c-arm and omega movement was stopped by the touch sensor, which is a safety feature.The damage to the x-ray beam limiting device unit was caused by the user's additional operation.So, there will be no further property damage.Although there was a possibility that the unit would fall from the c-arm body due to the rotation mechanism detaching, there was no possibility that the fallen unit could contact the patient or user considering the c-arm position.Therefore, there will be no personal injury.
Event or Problem Description
During automatic positioning, the c-arm and omega contacted.After that, a user attempted to keep the arms separated but operated as the arms were further strongly contacted by additional user operations.This caused damage to the x-ray beam limiting device unit and the occurrence of an error of this unit.After the study was finished, a customer engineer found that the rotation mechanism came off.There was no harm to the patient or user, nor any damage to surrounding equipment.This event did not affect the study because this happened at the end of the study.

• Brand Name: CANON
• Common Device Name: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): CANON INC.; 1385 shimoishigami; otawara-shi, tochigi 324-8 550; JA 324-8550
• Manufacturer (Section G): CANON MEDICAL SYSTEMS USA, INC.; 2441 michelle drive; tustin, CA 92780
• Manufacturer Contact: orlando tadeo ; 2441 michelle drive; tustin,, CA 92780 ; 7146697459
• MDR Report Key: 24772377
• Report Number: 2020563-2026-00004
• Device Sequence Number: 9925122
• Product Code: OWB
• UDI-Device Identifier: 04987670100222
• UDI-Public: (01)04987670100222
• Combination Product (Y/N): N
• PMA/510(K) Number: K253584
• 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
• Report Date (Section B): 04/02/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: INFX-8000V
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2026
• Initial Report FDA Received Date: 04/02/2026
• 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
• Patient Sex: Unknown