MAUDE Adverse Event Report: CANON MEDICAL SYSTEMS CORPORATION CANON; MAGNETIC RESONANCE DIAGNOSTIC DEVICE

Model Number	MEXL-3020/S5
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	04/10/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient experienced a skin burn on their upper thigh during a t-spine exam.There was no coil contact but the patient's thigh may have been touching the inner bore.The scan parameter for this exam indicated that the patient was rated as 375lbs and just fit the bore.
Additional Manufacturer Narrative
The device was evaluated by a canon representative.They performed auto snr with the head/neck/spine/body coil combination and the coil combination tested and judged as good with low noise standard deviation.The facility's use at the time of the reported issue is currently under investigation.
Additional Manufacturer Narrative
The device was evaluated by a canon representative.They performed auto snr with the head/neck/spine/body coil combination and the coil combination tested and judged as good with low noise standard deviation.The investigation concluded that due to the patient's size there was limited space within the gantry bore during imaging.It is highly likely that the patient's fingers were pressed directly against their posterior thigh.As a result of the this contact, an electric current was generated in the body loop formed by the side of the body and the arm.Additionally, due to the small contact area between the fingers and the thigh, the current density in that area increased, causing localized heating and resulting in burns.Contact between fingers and other parts of the human body is the most frequent cause for forming a human body loop.A caution regarding this is provided in the safety manual.The reported incident was caused by a user-related error.
Event or Problem Description
It was reported that a patient experienced a skin burn on their upper thigh during a t-spine exam.There was no coil contact but the patient's thigh may have been touching the inner bore.The scan parameter for this exam indicated that the patient was rated as 375lbs (height 5 fett 11 inches) and just fit the bore.

• Brand Name: CANON
• Common Device Name: MAGNETIC RESONANCE DIAGNOSTIC DEVICE
• Manufacturer (Section D): CANON MEDICAL SYSTEMS CORPORATION; 1385 shimioshigami; otawara, tochigi 32485 50; JA 3248550
• Manufacturer (Section G): CANON MEDICAL SYSTEMS CORPORATION; 1385 shimioshigami; otawara, tochigi 32485 50; JA 3248550
• Manufacturer Contact: orlando tadeo ; 2441 michelle drive; tustin, CA 92780 ; 7144831551
• MDR Report Key: 21996809
• Report Number: 2020563-2025-00004
• Device Sequence Number: 8641835
• Product Code: LNH
• UDI-Device Identifier: 04987670102615
• UDI-Public: (01)04987670102615
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2025

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: MEXL-3020/S5
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2025
• Supplement Date Received by Manufacturer: 10/19/2025
• Initial Report FDA Received Date: 05/09/2025
• Supplement Report FDA Received Date: 11/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Patient Weight: 170 KG