MAUDE Adverse Event Report: CANON MEDICAL SYSTEMS CORPORATION CANON; FLUOROSCOPIC X-RAY SYSTEM

Model Number INFX-8000V

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hair Loss (1877)

Event Date 02/02/2018

Event Type  Injury  

Manufacturer Narrative

A physician reported that five patients had hair loss following use of the system.

Event Description

Physician reported that five of his patients had hair loss following use of the system.

Manufacturer Narrative

In a letter dated march 13, 2018 we received questions on report number 2020563-2018-00002 and responded to it in an email to (b)(6) dated (b)(6) 2018.Dr.(b)(6) responded in an email dated (b)(6) 2018 that our response adequately addressed their requests.Please reference the information included in our (b)(6) 2018 response.The manufacturer conducted an investigation and it has been determined that the issue was not due to a device malfunction of the system.

• Brand Name: CANON
• Type of Device: FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): CANON MEDICAL SYSTEMS CORPORATION; 1385 shimoishigami; otawara-shi, tocchigi 324-8 550; JA 324-8550
• MDR Report Key: 7324553
• MDR Text Key: 101954423
• Report Number: 2020563-2018-00002
• Device Sequence Number: 1
• Product Code: JAA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/13/2018

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: INFX-8000V
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/06/2018
• Initial Date FDA Received: 03/08/2018
• Supplement Dates Manufacturer Received: 02/06/2018
• Supplement Dates FDA Received: 04/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other