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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CANON MEDICAL SYSTEMS CORPORATION CANON; SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED
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CANON MEDICAL SYSTEMS CORPORATION CANON; SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED Back to Search Results
Model Number INFX-8000F/BGUP
Device Problem Difficult or Delayed Activation (2577)
Patient Problem Perforation of Vessels (2135)
Event Date 11/11/2020
Event Type  Injury  
Manufacturer Narrative
According to the log analysis on the incident day, the xb1 hv error occurred when the user irradiated with the high tube current.The xb1 error will occur when the tube current output exceeds the threshold (about 1080ma) to protect the high voltage generator.When the error occurred, the system displayed the dialog box to select "reset" or "reduce", and the user selected "reduce" as the recovery operation.This operation is the user's decision.The user manual contains the description of "reset" and "reduce" as follows: even if a system error related to fluoroscopy, radiography, or image operation occurs, it is often possible to reset the error.In such cases, the system returns to its normal operation status after the error is reset.Even when the error cannot be reset, if the error correction function can be activated, operation can be switched to reduced operation.Reduced operation permits the minimum required procedures, such as removal of the catheter, to be performed.Customer engineer replaced the power supply unit after the event.The investigation of returned parts will be performed to find the cause for the error occurrence after they arrive to the manufacturer.
 
Event Description
Customer reported that during a cardiac study, while using the cas-810a arm, an xb1 hight voltage generator error occurred causing x-ray production to stop.Customer alleged that the error occured while a balloon was inflated within the patient.The customer enabled the other arm (cas-830b) and continued the procedure, at which time the staff observed a vascular perforation.Following the procedure, the patient received surgery due to their condition.The customer rebooted the system after the procedure, and the error cleared.Customer noted that they do not know whether there is any connection between the interruption of x-ray production and the adverse event.As of november 16th, 2020, patient is reported to be alive, but in critical condition.Canon customer engineer replaced the power supply unit on november 18th, 2020, and canon service reported that the system was operating afterwards without any issues.
 
Manufacturer Narrative
According to the log analysis on the incident day, the xb1 hv error occurred when the user irradiated with the high tube current.The xb1 error will occur when the tube current output exceeds the threshold (about 1080ma) to protect the high voltage generator.When the error occurred, the system displayed the dialog box to select "reset" or "reduce", and the user selected "reduce" as the recovery operation.This operation is the user's decision.The user manual contains the description of "reset" and "reduce" as follows: even if a system error related to fluoroscopy, radiography, or image operation occurs, it is often possible to reset the error.In such cases, the system returns to its normal operation status after the error is reset.Even when the error cannot be reset, if the error correction function can be activated, operation can be switched to reduced operation.Reduced operation permits the minimum required procedures, such as removal of the catheter, to be performed.Customer engineer replaced the power supply unit after the event.The investigation of returned parts will be performed to find the cause for the error occurrence after they arrive to the manufacturer.As a result of the investigation of returned parts (x-ray tube device, high voltage generator), no abnormalities could be found in the parts.As a result of further investigation, it was found that the temperature of the filament of the x-ray tube device raised at the event because the x-ray exposure switch was repeatedly operated in a short time (1sec or less) with the high tube current setting, and as a result, the high voltage device stopped to protect the overcurrent of the tube current.System instructions do not recommend repeated the exposure under high conditions in order to reduce radiation exposure to a patient.This method of switch operation by this user is unique, and if the user continues to use this method, the x-ray tube device may break faster than expected life span.However, in this system, if the user wants to exposure at the exposure time longer than the default exposure time, it is recommended to change the exposure time setting instead of repeating the exposures.Also, it is suggested the user to operate the exposure under lower conditions.This is outlined in the system operation manual.No corrective action is required, as the incident was determined not to be caused by the device.Preventative action includes proposing to the user to refrain from repeatedly operating the exposure switch within a short time, and to change the default setting value of exposure time to longer one.Also, it will besuggested the user to operate the exposure under lower conditions.
 
Event Description
Customer reported that during a cardiac study, while using the cas-810a arm, an xb1 hight voltage generator error occurred causing x-ray production to stop.Customer alleged that the error occured while a balloon was inflated within the patient.The customer enabled the other arm (cas-830b) and continued the procedure, at which time the staff observed a vascular perforation.Following the procedure, the patient received surgery due to their condition.The customer rebooted the system after the procedure, and the error cleared.Customer noted that they do not know whether there is any connection between the interruption of x-ray production and the adverse event.As of (b)(6), 2020, patient was reported to be alive, but in critical condition.Canon customer engineer replaced the power supply unit on (b)(6), 2020, and canon service reported that the system was operating afterwards without any issues.
 
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Brand Name
CANON
Type of Device
SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED
Manufacturer (Section D)
CANON MEDICAL SYSTEMS CORPORATION
1385 shimioshigami
otawara-shi, tochigi 324-8 550
JA  324-8550
MDR Report Key11014046
MDR Text Key221829978
Report Number2020563-2020-00007
Device Sequence Number1
Product Code JAA
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Remedial Action Replace
Type of Report Initial,Followup
Report Date 04/13/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/15/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberINFX-8000F/BGUP
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/15/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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