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

Model Number INFX-8000V/J4

Device Problem Device Handling Problem (3265)

Patient Problem Injury (2348)

Event Date 06/28/2020

Event Type  Injury  

Manufacturer Narrative

During the incident, it appears that the touch sensor on the base cover operated as intended, and the c-arm evacuated from the pinched leg.At that time, no error had occurred.The device appears to be working properly and the customer themselves acknowledged responsibility for this matter.The injured doctor went to the hospital for treatment, and returned to work the next day.This issue has been attributed to user error.Additionally, the operation manual was provided to all customers as a warning of this incident in (b)(6) 2013.Furthermore, in (b)(6) 2016, a warning poster and label were provided to all customer for the notification again.This issue has only been reported at (b)(6) hospitals.

Event Description

During intubation work in c-arm head position, customer alleged that the doctor broke his fibula after leg was pinched between the base cover and c-arm of the system when the operator moved the c-arm without noticing the doctor's leg position.

• 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
• 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 ; 7307500780
• MDR Report Key: 10311582
• MDR Text Key: 199988508
• Report Number: 2020563-2020-00005
• 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: foreign
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 07/03/2020

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/J4
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/22/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other