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FUJIFILM

FUJIFILM CORPORATION · Model BS-4 · UDI-DI 04547410467284

FDF FDA Prescription

510(k) clearances

78,289

Adverse events (63 deaths)

Recalls

Facilities

Description

This product is used in combination with FUTIFILM Double Balloon Endoscopes at medical facilities under the management of physicians. Being attached to the endoscope, this product is inserted into the digestive tract from the mouth or anus to stabilize the distal end of the endoscope to the digestive tract's mucous membrane. Do not use this product for any other purposes. This product is not intended for use for any neonates , infants or children

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.