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FUJIFILM

FUJIFILM CORPORATION · Model EG-450CT5 · UDI-DI 04547410330991

FDS

510(k) clearances

76,757

Adverse events (54 deaths)

Recalls

Facilities

Description

This product is a medical Endoscope for the upper digestive tract. It is intended for observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenal bulb at medical facilities under management of physicians.

Recalls

Date	Firm	Reason
2024-10-31	Olympus Corporation of the Americas	High-level disinfection ("HLD") with Acecide-C disinfectant in the Olympus OER-Pro Automated Endoscope Reprocessor ("AER") has been removed as a compatible reprocessing method from
2024-09-18	Olympus Corporation of the Americas	To better define the drying procedures described in the IFU to improve the instructions for easier understanding of each drying step after human errors and concerns were identified
2023-07-27	Aomori Olympus Co., Ltd.	The Distal Attachment contain di-2-ethylhexyl phthalate (DEHP), which exceeds the permissible exposure level calculated according to ISO 10993-17: 2002
2023-07-27	Aomori Olympus Co., Ltd.	The Distal Attachment contain di-2-ethylhexyl phthalate (DEHP), which exceeds the permissible exposure level calculated according to ISO 10993-17: 2002
2022-04-22	Olympus Corporation of the Americas	Part (A-rubber) intended for a different model of gastrointestinal videoscope may have been used when replacing part on GIF-HQ190 during the last repair at Olympus. An Incorrect A
2020-10-16	Olympus Corporation of the Americas	A new inspection step was added to the cleaning and disinfection section of the Instructions For Use (IFU) for this device in order to reduce the risk of causing patient infections
2020-10-16	Olympus Corporation of the Americas	A new inspection step was added to the cleaning and disinfection section of the Instructions For Use (IFU) for this device in order to reduce the risk of causing patient infections
2017-02-17	Fujifilm Medical Systems U.S.A., Inc.	Fujifilm is recalling multiple endoscopes after a retrospective review.
2016-08-15	Pentax of America Inc	PENTAX Medical is initiating this field action to provide customers that have purchased the affected endoscopes with the most recent Operation and Reprocessing IFUs.
2016-04-06	Pentax Medical Company	Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an endoscope's instrument channel.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.