Violation Tracker Individual Record

Company: 
Olympus Medical Systems Corporation
Current Parent Company: 
Olympus
Penalty: 
$85,000,000
Year: 
2018
Date: 
December 10, 2018
Offense Group: 
safety-related offenses
Primary Offense: 
drug or medical equipment safety violation
Violation Description: 

Olympus Medical Systems Corporation and a former senior executive in Japan pleaded guilty to failing to file required adverse event reports involving infections connected to duodenoscopes, and to continuing to sell the duodenoscopes in the United States despite those failures.

Level of Government: 
federal
Action Type: 
agency action
Agency: 
Justice Department Civil Division
Civil or Criminal Case: 
criminal
HQ Country of Parent: 
Japan
Ownership Structure of Parent: 
publicly traded
Major Industry of Parent: 
electrical and electronic equipment
Specific Industry of Parent: 
imaging products
Source Notes: 
If an online information source is not working, check the Violation Tracker Data Sources page for an updated link.
Parent company note: 
Parent-subsidiary relationship is current as of the most recent revision listed in the Update Log.