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DiLumen C2

LUMENDI LLC · Model DiLumen C2.2 130 cm · UDI-DI 00858836007065

FDF Prescription

510(k) clearances

84,519

Adverse events (63 deaths)

Recalls

Facilities

Description

DiLumen C2 consists of a soft flexible sheath that fits over standard endoscopes. The device employs two balloons, one behind the bending section of the endoscope and the second in front of the tip of the endoscope. When both balloons are deployed, and inflated the area in between is stabilized. This Therapeutic Zone (TZ) facilitates stabilization, insufflation and manipulation of the tissue thus allowing the clinician to effectively treat the target area. The device also has two flexible tool channels attached on the outside of the sleeve at the 3 and 6 o'clock positions. These tool channels accommodate flexible endoscopic instruments used to perform endoscopic interventions. This version DiLumen C2 is designed to work with the DiLumen Elbow Ig.

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.