MAUDE Adverse Event Report: CANON MEDICAL SYSTEMS CORPORATION CANON; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED

Model Number TSX-301A/2D

Device Problem Use of Device Problem (1670)

Patient Problem Injury (2348)

Event Date 05/22/2020

Event Type  Injury  

Manufacturer Narrative

To ensure safety, precautions to be observed are provided in the operation manual.Excerpt from the operation manual (2b201-617en): the patient must be immobilized at least two locations: elbows and knees.It was concluded that the phenomenon was caused by "user error".This event occurred due to immobilizing bands not being used at the knees, which is mentioned in the operation manual.

Event Description

The customer reported a patient kicked the mylar ring during exam, making contact with the optics assembly.Patient's knee was injured and it was reported patient underwent surgery.The extent of the injuries has not been obtained after multiple follow up attempts.Patient was reported to be kyphotic, with limited mental capacity.Scan images prior to the injury demonstrate the patient was on their back with their legs bent at the hip, at an 80 to 90 degree angle.A single restraint was used, one wide strap across mid section of patient.The knees were not fixed.No errors occurred on the system during or leading up to this adverse event.The mylar ring was replaced.

• Brand Name: CANON
• Type of Device: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): CANON MEDICAL SYSTEMS CORPORATION; 1385 shimoishigami; otawara-shi, 324-8 550; JA 324-8550
• Manufacturer (Section G): CANON MEDICAL SYSTEMS CORPORATION; 1385 shimoishigami; otawara-shi, 324-8 550; JA 324-8550
• Manufacturer Contact: paul biggins ; 2441 michelle drive; tustin, ca ; 7305000780
• MDR Report Key: 10179464
• MDR Text Key: 195962689
• Report Number: 2020563-2020-00003
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093891
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Administrator/Supervisor
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 06/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TSX-301A/2D
• Was Device Available for Evaluation?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 05/28/2020
• Date Device Manufactured: 11/01/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other