MAUDE Adverse Event Report: CANON INC. Canon; MAGNETIC RESONANCE DIAGNOSTIC DEVICE

Model Number	MEXL-1510/S3
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	11/12/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2025, a patient received a burn compatible with their right lower extremity (rle) resting against diacor mr-tek350 stainless steel portion of stirrup.The patient underwent epidural for high dose radiation (hdr) procedure which required patient's bilateral lower extremities to be positioned in diacor stirrups.The patient was taken to mri for verification of needle placement.Following hdr procedure nursing staff noticed wound to patient's right outer thigh.Area was red with a large white/blanched area in the center resembling a burn.The patient returned for their 1-week follow-up for the hdr procedure and reported worsening of wound.The patient required care at advanced wound care center.Per mri safety officer patient experienced "mri burn" from touchpoint of rle with stainless steel component of zephyr stirrup hinge.The patient likely did not experience sensation of "burn" or pressure during mri testing due to the epidural received for the hdr procedure.This reported incident (mw5180429) was received by canon via the fda's medwatch program.

• Brand Name: Canon
• Common Device Name: MAGNETIC RESONANCE DIAGNOSTIC DEVICE
• Manufacturer (Section D): CANON INC.; 1385 shimioshigami; otawara, tochigi 32485 50; JA 3248550
• Manufacturer (Section G): CANON INC.; 1385 shimioshigami; otawara, tochigi 32485 50; JA 3248550
• Manufacturer Contact: orlando tadeo ; 2441 michelle drive; tustin, CA 92780 ; 7144831551
• MDR Report Key: 23962290
• Report Number: 2020563-2025-00013
• Device Sequence Number: 14639169
• Product Code: LNH
• UDI-Device Identifier: 04987670101601
• UDI-Public: (01)04987670101601
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 07/27/2026

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: MEXL-1510/S3
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2025
• Supplement Date Received by Manufacturer: 07/08/2026
• Initial Report FDA Received Date: 01/05/2026
• Supplement Report FDA Received Date: 07/27/2026
• 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: Hospitalization
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Weight: 187 LB
• Patient Race: White