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

Model Number	INFX-8000V/B6
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/14/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2026 during the transfer from the hospital bed / gurney to the procedure table a patient became unstable while being moved to the procedure table and slipped.Hospital staff caught the patient before he hit the floor and the patient received no injuires as a result of this incident.
Additional Manufacturer Narrative
The complainant stated that the mattress used on the patient table is too short on each side which may have contributed to the incident.Furthermore, the mattress used at this facility was not manufactured by our company.

• Brand Name: CANON INC.
• Common Device Name: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): CANON INC.; shimomaruko 3-chome 30-2; ohta-ku, tokio 146-8 501; JA 146-8501
• Manufacturer (Section G): CANON INC.; shimomaruko 3-chome 30-2; ohta-ku, tokio 146-8 501; JA 146-8501
• Manufacturer Contact: orlando tadeo ; 2441 michelle drive; tustin, CA 92780 ; 7144831551
• MDR Report Key: 25166893
• Report Number: 2020563-2026-00005
• Device Sequence Number: 21463696
• Product Code: OWB
• UDI-Device Identifier: 04987670100222
• UDI-Public: 04987670100222
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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): 05/13/2026

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/B6
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/20/2026
• Initial Report FDA Received Date: 05/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (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: Unknown