FDA Slaps Olympus With Another Endoscope Warning
The US FDA recently rebuked Tokyo-based medical device firm Olympus for failing to adhere to good manufacturing practices for its endoscopes and for not investigating complaints related to the devices.
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The US FDA has cleared a new endoscopy system from Olympus along with two compatible gastrointestinal endoscopes for the diagnosis and treatment of a range of GI issues.
FDA Issues Back-To-Back Warnings To Major Endoscope Maker Amid Device Reporting And Quality Systems Concerns
The US Food and Drug Administration issued warning letters in 2022 to Japanese device maker Olympus Medical Systems Corporation and a subsidiary concerning good manufacturing practices related to its endoscopes.
A new review of adverse event data found reports tied to each of six endoscope categories rose significantly between 2014 and 2021. For gastroscopes, the rise was an eye-popping 8,630%.