MAUDE Adverse Event Report: CANON MEDICAL SYSTEMS CORPORATION CANON; MAGNETIC RESONANCE IMAGING SYSTEM

Model Number MRT-1504/S4

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Laceration(s) (1946)

Event Date 06/14/2021

Event Type  Injury  

Manufacturer Narrative

Customer stated that this incident occured during training.Canon customer engineer confirmed that there are warning signs on entrance door of mr suite cautioning not to enter suite with any ferromagnetic materials, specifically cautioning against entering suite with ferromagnetic wheelchairs.This incident is attributed to user error.It was communicated verbally from customer to customer engineer that beyond the aforementioned stitches, the injured party has gone to doctor and then back to hospital due to continued swelling of his scrotum.According to customer and customer engineer, it is presumed that staff were aware that the wheelchair was magnetic, but presumably, to save time, staff would bring wheelchair into the room to the far end of the couch to transfer patients rather than take the time to transfer them from the magnetic wheelchair to non-magnetic wheelchair, and then to couch.As of june 17th, 2021, system is up and running once again.

Event Description

Customer alleged that mr tech became pinned between magnetic wheelchair and magnet.Customer noted that another mr tech quenched the magnet to rescue the pinned tech.Customer stated that tech walked to the er on his own, complaining of pain in arm and testicles.Tech reportedly received stitches in his groin area as a result.

• Brand Name: CANON
• Type of Device: MAGNETIC RESONANCE IMAGING 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: paul biggins ; 2441 michelle drive; tustin, CA 92780 ; 7147305000
• MDR Report Key: 12094865
• MDR Text Key: 259250771
• Report Number: 2020563-2021-00002
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 06/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MRT-1504/S4
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/17/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention