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DiLumen EZ1, 130 cm

LUMENDI LLC · Model DiLumen EZ1, 130 cm · UDI-DI 00858836007171

FDF Prescription

510(k) clearances

81,392

Adverse events (63 deaths)

Recalls

Facilities

Description

The Lumendi DiLumen EZ1 is an endoscope accessory intended to ensure complete positioning of an endoscope in the large intestine, and assist with optical visualization, diagnosis, and endoscopic treatment. The DiLumen EZ1 consists of a soft flexible sheath that fits over standard endoscopes. The device employs a single balloon behind the bending section of the endoscope. When the balloon is inflated it contacts the intestine wall and provides stability to the endoscope.

Recalls

Date	Firm	Reason
2024-01-11	Olympus Corporation of the Americas	Specific repaired colonovideoscopes were assembled without an adhesive which protects them from certain physical conditions such as high levels of vibration, fluctuation in tempera
2024-01-11	Olympus Corporation of the Americas	Specific repaired colonovideoscopes were assembled without an adhesive which protects them from certain physical conditions such as high levels of vibration, fluctuation in tempera
2024-01-11	Olympus Corporation of the Americas	Specific repaired colonovideoscopes were assembled without an adhesive which protects them from certain physical conditions such as high levels of vibration, fluctuation in tempera
2023-10-16	Aizu Olympus Co., Ltd.	Specific devices may have an improperly repaired light guide connector due to missing adhesive to secure the suction channel mouthpiece to the scope connector. Issue may result in
2023-10-16	Aizu Olympus Co., Ltd.	Specific devices may have an improperly repaired light guide connector due to missing adhesive to secure the suction channel mouthpiece to the scope connector. Issue may result in
2023-10-16	Aizu Olympus Co., Ltd.	Specific devices may have an improperly repaired light guide connector due to missing adhesive to secure the suction channel mouthpiece to the scope connector. Issue may result in
2023-10-16	Aizu Olympus Co., Ltd.	Specific devices may have an improperly repaired light guide connector due to missing adhesive to secure the suction channel mouthpiece to the scope connector. Issue may result in
2023-10-16	Aizu Olympus Co., Ltd.	Specific devices may have an improperly repaired light guide connector due to missing adhesive to secure the suction channel mouthpiece to the scope connector. Issue may result in
2023-10-02	Olympus Corporation of the Americas	Sterilization failures when devices are sterilized per the Reprocessing Manual due to lack of drying time for the endoscope channel.
2023-09-25	Aizu Olympus Co., Ltd.	Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endo

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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.