Image, Illumination, Fiberoptic, For Endoscope
FDA adverse event reports and recall history for image, illumination, fiberoptic, for endoscope (product code FFS), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 340
- Deaths
- 2
- Injuries
- 43
- Malfunctions
- 259
Reports per year
Source: FDA adverse event reports by year received, 2010–2024. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2017-06-05TerminatedDevice Design
Vue Optic Visualization Source, Flexor Vue Deflecting Endoscopic System, Endoscope, Fiber Optic, Supplied sterilized by ethylene oxide gas in peel-open packages
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 reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and sterilization of these products.
- 2007-06-07TerminatedNonconforming Material/Component
Smith & Nephew, 420XL Xenon Light Source, 180 Watt; for endoscopic use. Catalog/Part #72200510; manufactured for Smith & Nephew Endoscopy, Andover, MA 01810.
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 causing the light to cease operating. The problem can occur anytime: from the initial turning on (powering up), to anytime during use.
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