Light Source, Fiberoptic, Routine
FDA adverse event reports and recall history for light source, fiberoptic, routine (product code FCW), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 2,946
- Deaths
- 1
- Injuries
- 150
- Malfunctions
- 2,774
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2023-04-28Open, ClassifiedEmployee error
SafeLight Fiber Optic Cable: Clear, 5MM X 10FT 3.05M, REF: 0233-050-100; Gray, 5MM X 10FT 3.05M, REF: 0233-050-200
Fiber optic cables assembled with not enough epoxy on the proximal end, creating light output issues, which could cause a clinical delay or procedure being converted to open.
- 2011-12-02TerminatedProcess control
Integra Surgical Luxtec MLX Light Source Catalog Numbers: 00MLX Product Usage: The Integra Luxtec MLX Light Source is designed to supply high intensity white light through a fiber optic cable for illumination of a surgical field during a surgical and or medical procedure.
A loose screw may result in shifting of components and improper function of the turret or actuator assembly.
- 2011-12-02TerminatedProcess control
Integra Surgical Luxtec MLX Light Source Catalog Numbers: 00MLXAU Product Usage: The Integra Luxtec MLX Light Source is designed to supply high intensity white light through a fiber optic cable for illumination of a surgical field during a surgical and or medical procedure.
A loose screw may result in shifting of components and improper function of the turret or actuator assembly.
- 2011-12-02TerminatedProcess control
Integra Surgical Luxtec MLX Light Source Catalog Numbers: 00MLXEU
A loose screw may result in shifting of components and improper function of the turret or actuator assembly.
- 2011-04-25TerminatedProcess change control
Luxtec MLX 300 Watt Xenon Light Source, Model OOMLX; Surgical/Medical Light Source This light source is designed to supply high-intensity light to a fiber optic cable for illumination of a surgical field during a surgical and/or medical procedure.
Malfunction of the MLX Control Board may cause loss of manual control and Lamp shut down.
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