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

Model Number TSX-101A/8A

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Laceration(s) (1946)

Event Date 11/11/2021

Event Type  Injury  

Manufacturer Narrative

It was found that the phenomenon occurred due to lack of attention by personnel when repositioning patient, thus caused by user error.To ensure safety, precautions to be observed are provided in the operation manual.Excerpt from the operation manual ((b)(4)) states: "be sure to use the couch accessories correctly.Otherwise, personal injury or damage to the system may result." additionally, to prevent the recurrence of such accidents or preparation of protective equipment, the hospital will be purchasing cushion(s) for the headrest.

Event Description

Incident occurred at a hospital in (b)(6) during patient repositioning on couch top for head scanning.Patient hit their head (parietal region) against the corner of the headrest resulting in a 6 cm laceration.It was reported 3 personnel held and slid the patient's body towards the headrest for repositioning.The patient received topical treatment and required use of medical stapler to close wound.

• Brand Name: CANON
• Type of Device: SYSTEM, X-RAY TOMOGRAPHY COMPUTED
• Manufacturer (Section D): CANON MEDICAL SYSTEMS CORPORATION; 1385 shimioshigami; 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: 12960128
• MDR Text Key: 282849374
• Report Number: 2020563-2021-00006
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TSX-101A/8A
• Date Manufacturer Received: 11/29/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other