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

Model Number MEXL-1504/U4

Device Problems Insufficient Information (3190); Device Handling Problem (3265)

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Date 09/26/2021

Event Type  Injury  

Manufacturer Narrative

Investigation of root cause is in progress.

Event Description

Customer alleged that atlas speeder body coil was in contact with patient skin in groin area while doing a pelvis exam, causing a visible burn spot.Patient was placed on the table feet first.Patient's legs were red and swollen with cellulitis prior to scan.Customer noted that abdomen coil was placed over pelvis and pad placed between power cord and patient.Customer alleged that patient's legs were separated about an inch apart and not touching one another.Customer stated that no pad was used because operator did not want the irritated skin touching and sticking to the pads.Operator ran several scouts and a sag t2 studies on pelvis.Patient squeezed the alarm and told operator that patient felt warmth between her legs in the groin area.Customer states that operator pulled the table out of the magnet to ensure that nothing in system was creating a loop, and re-checked that patient's legs were separated, and patient stated that she experienced a warm sensation while the scan was running.Operator informed patient that he would attempt the scan again, and if she felt pain or intense heat in her groin to let the operator know, and they would then discontinue the scan.Operator talked to patient throughout the scan.Customer alleged that patient did not mention that her groin area was experiencing pain until after scan was complete, and patient was on the stretcher going back to her bed.Operator notified both the patient's nurse and doctor of her complaints and several minutes later, another nurse called the operator stating that the patient had blisters on her skin between her legs.

Manufacturer Narrative

Manufacturer states that as a result of the incident investigation, no problem was found with the device or rf coils.Manufacturer presumes one of the following scenarios to be the cause.[probable cause 1] customer alleged that the blistered area of the patient was between the thighs, which is not a place where the coil can make contact if the appropriate padding is in place.Since no padding was used between the thighs of the patient, the manufacturer presumes that the patient moved during the scan and made contact between the non-padded area, forming a human body loop and causing the burn.[probable cause 2] the blistered area is outside the transmitter coil, so the rf effect is minor.The patient did not complain of any warmth to the blistered area in the latter part of the scan.Results of technical consideration: the inner thigh is more likely to come in contact with the skin in bariatric patients.The patient's sensation was decreased due to cellulitis, and it may have been difficult for the patient to feel warmth at the skin contact area.In this case, the image was taken per the "first level controlled operation mode for sar".The manual cautions that extreme caution must be taken when examining "patients who have reduced sensation in any part of the body".Canon safety manual 2b900-399en.In regards to corrective action, the local ce or applications staff will explain to the customer to put in the pad as described in the operation manual, and reference safety manual 2b900-399en.As there was no problem with the device or the operation manual, manufacturer states that no preventative action is needed for this case.

Event Description

Customer alleged that atlas speeder body coil was in contact with patient skin in groin area while doing a pelvis exam, causing a visible burn spot.Patient was placed on the table feet first.Patient's legs were red and swollen with cellulitis prior to scan.Customer noted that abdomen coil was placed over pelvis and pad placed between power cord and patient.Customer alleged that patient's legs were separated about an inch apart and not touching one another.Customer stated that no pad was used because operator did not want the irritated skin touching and sticking to the pads.Operator ran several scouts and a sag t2 studies on pelvis.Patient squeezed the alarm and told operator that patient felt warmth between her legs in the groin area.Customer states that operator pulled the table out of the magnet to ensure that nothing in system was creating a loop, and re-checked that patient's legs were separated, and patient stated that she experienced a warm senstation while the scan was running.Operator informed patient that he would attempt the scan again, and if she felt pain or intense heat in her groin to let the operator know, and they would then discontinue the scan.Operator talked to patient throughout the scan.Customer alleged that patient did not mention that her groin area was experiencing pain until after scan was complete, and patient was on the stretcher going back to her bed.Operator notified both the patient's nurse and doctor of her complaints and several minutes later, another nurse called the operator stating that the patient had blisters on her skin between her legs.

• 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 ; 7147307500
• MDR Report Key: 12712464
• MDR Text Key: 284290902
• Report Number: 2020563-2021-00005
• 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: Non-Healthcare Professional
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 12/14/2021

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 Operator: Health Professional
• Device Model Number: MEXL-1504/U4
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 09/28/2021
• Initial Date FDA Received: 10/28/2021
• Supplement Dates Manufacturer Received: 09/28/2021
• Supplement Dates FDA Received: 12/14/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female