FDAFDA · Alimentos y medicamentos·N.º oficial Z-1252-2017
Uretero-reno videoscope URF-V2 and URF-V2R endoscope and accessories The URF-V2/V2R endoscopes are intended for use in endoscopic diagnosis and treatment within the ureter and kidney.
Publicado el 8 de marzo de 2017 · Inicio del retiro: 12 de diciembre de 2016
Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
Olympus has received complaints regarding the breakage of the endoscope's insertion tube bending section during surgical procedures. Some of these complaints are associated with tissue trauma, including perforation, and insertion tubes which were stuck inside the patient and had to be surgically removed.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Olympus Corporation of the Americas
- Distribuidor
- Worldwide distribution-US Nationwide and country of: Canada.
- Lote
- All serial numbers
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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