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Speedboat RS2 8 Fr Instrument

CREO MEDICAL LIMITED · Model 7-RS2-003 · UDI-DI 05060359560575

KNS Prescription

510(k) clearances

17,476

Adverse events (81 deaths)

125

Recalls

118

Facilities

Description

A sterile, flexible, invasive, endoscopic device assembly intended to deliver: 1) a submucosal lifting solution; 2) an electrosurgical current in a bipolar configuration to tissues for cutting; and 3) microwave energy to tissues for coagulation. It is typically intended to treat gastrointestinal mucosal polyps/lesions through lifting of the diseased mucosa over a bubble of fluid, and subsequent electrosurgical excision of the diseased area. It includes a submucosal injection needle, an electrosurgical electrode, and a microwave tip, connected by a flexible sheath to a handpiece which includes controls (e.g., needle deployment control)/solution injection port. This is a single-use device.

Recalls

Date	Firm	Reason
2026-08-19	Olympus Corporation of the Americas	Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive.
2026-08-19	Olympus Corporation of the Americas	Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive.
2026-08-19	Olympus Corporation of the Americas	Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive.
2026-08-19	Olympus Corporation of the Americas	Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive.
2026-01-07	Olympus Corporation of the Americas	Devices which did not undergo thermoforming could deform and lose performance.
2026-01-07	Olympus Corporation of the Americas	Devices which did not undergo thermoforming could deform and lose performance.
2026-01-07	Olympus Corporation of the Americas	Devices which did not undergo thermoforming could deform and lose performance.
2026-01-07	Olympus Corporation of the Americas	Devices which did not undergo thermoforming could deform and lose performance.
2026-01-07	Olympus Corporation of the Americas	Devices which did not undergo thermoforming could deform and lose performance.
2026-01-07	Olympus Corporation of the Americas	Devices which did not undergo thermoforming could deform and lose performance.

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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.