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G-EYE Colonoscope

SMART MEDICAL SYSTEMS LTD · Model G-EYEH180AI · UDI-DI 07290018671283

FDF Prescription

510(k) clearances

84,519

Adverse events (63 deaths)

Recalls

Facilities

Description

The G-EYE® colonoscope is intended to be used with a compatible video processor (including light source), documentation equipment, monitor, endotherapy device such as a biopsy forceps, and other ancillary equipment for endoscopy and endoscopic surgery within the lower gastrointestinal tract including the anus, rectum, sigmoid colon, colon and ileocecal valve. It incorporates a balloon at the distal end of the colonoscope to maintain central positioning within the lumen and help control the endoscope’s view field and/or endoscope positioning.

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.