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

Model Number TSX-303A/5L

Device Problem Use of Device Problem (1670)

Patient Problem Laceration(s) (1946)

Event Date 02/13/2021

Event Type  Injury  

Manufacturer Narrative

Adverse event took place on (b)(6) 2021, due to legal action being taken by patient's family, this initiated further investigation into the incident.The er doctor stated in their report from 2021 that the laceration occurred on a gurney.Further investigation in recent weeks revealed the event occurred in/on the ct couch.It was reported patient expired a few days later and that the patient was transferred and passed away somewhere else, thus cause of death is unknown.Facility does state the patient's passing was not a result from the laceration received from this adverse event.Both the radiology director and the risk management officer have since left greenwood leflore hospital for new employment and no further information can be obtained.To ensure safety, precautions to be observed are provided in the operation manual.Excerpt from the operation manual 2b201-663en, "be sure to mount the couch accessories securely.Otherwise, the accessories may fall, or the mounting sections may be damaged, resulting in personal injury.Be sure to use the couch accessories correctly.Otherwise, personal injury or damage to the system may result." it was concluded that the phenomenon was caused by "user error".This event occurred due to lack of attention and care when repositioning patient.As a countermeasure to ensure further safety, manufacture anticipates issuing a field service instruction (fsi) around june 2022.Fsi will assert caution and to being extremely careful when moving patients.

Event Description

Patient received a laceration while being repositioned for a ct scan.The technologist and transporter of the patient transferred the patient from the stretcher to the ct couch.When being repositioned up the couch into the head holder for scanning, patient's head hit the carbon fiber head holder resulting in a laceration.Patient required stitches.It was reported that the patient had an altered level of consciousness (aloc) prior to the adverse event.There were no other injuries or symptoms reported after injury occurred.

• Brand Name: CANON
• Type of Device: SYSTEM, X-RAY TOMOGRAPHY COMPUTED
• 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: 14185935
• MDR Text Key: 289856858
• Report Number: 2020563-2022-00002
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 04/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TSX-303A/5L
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other