FDAFDA · Alimentos y medicamentos·N.º oficial Z-1191-2019
Obturator (long cone), Part number 25162 Product Usage: The obturator is a component of the Flex Rectoscope which is an accessory to the Flex Robotic System. The Medrobotics Flex Robotic System is intended to provide robot-assisted control of the Flex Colorectal Drive during visualization of and surgical site access to the anus, rectum and distal colon. The Flex Robotic System is intended for use in adults (e22 years of age). The Flex Colorectal Drive is intended for robot-assisted visualization of and surgical site access to the anus, rectum, and distal colon in adults (e22 years of age). The Flex Colorectal Drive also provides accessory channels for compatible flexible instruments used in surgery.
Publicado el 24 de abril de 2019 · Inicio del retiro: 25 de enero de 2019
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
The weld may break, resulting in the rod separating from the cone of the long and short cone Obturators.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Medrobotics Corporation
- Distribuidor
- Worldwide Distribution - US Nationwide in the states of CO, DC, FL, IL, MD, MO, NY, OK, PA, TX, and VA. Foreign distribution to Australia and Italy.
- Lote
- lots 18832-17, 19042-07, 19042-01, 19199-01, 18832-17, 19669-05, 19684-05
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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