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Fiber Optic Light Cable

GULF FIBEROPTICS, INC. · Model 3.8mm bundle diameter, 8.5' length, bifurcated cable · UDI-DI 00857580006331

FFS HBI

510(k) clearances

340

Adverse events (2 deaths)

Recalls

Facilities

Description

A flexible fiber optic cable that is designed to transport light from a light source to an instrument or other equipment, e.g., an endoscope or a headlight. The fiber optic bundle is protected within a sheath and is made of glass fibers. Each end of the cable is encased in a metal connector that fits into the respective instruments/equipment and also protects the end of the fiber optic bundle. This is a reusable device.

Recalls

Date	Firm	Reason
2017-05-03	Cook Inc.	Cook Inc. is initiating a voluntary recall of the Vue Optic Visualization Source and the Flexor Vue Deflecting Endoscopic System because it was determined that the current reproces
2007-04-09	Smith & Nephew, Inc Endoscopy Division	Several units were manufactured using a power supply that contains a 1 amp fuse where a 5 amp fuse is required. When the unit's power supply draws more that 1A, the fuse will fail

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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.