FDAFDA · Alimentos y medicamentos·N.º oficial Z-1442-2013
8 mm Monopolar Curved Scissors (a.k.a. Hot Shears) Manufactured and Distributed by: Intuitive Surgical Sunny vale, CA The EndoWrist Monopolar Curved Scissors Instrument is a multiple-use endoscopic instrument utilizing a single use, tip cover accessory, to be used in conjunction with the Intuitive Surgical Endoscopic Instrument Control System.
Publicado el 12 de junio de 2013 · Inicio del retiro: 8 de mayo de 2013
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
Intuitive Surgical has identified a potential for some units of the Monopolar curved Scissors version 09 and 10 instruments to develop very small cracks near the distal end. This may create a pathway for electrosurgical energy to leak to tissue and potentially cause thermal injury.
Qué hacer
Voluntary: Firm initiated · E-Mail
Detalles del retiro
- Fabricante
- Intuitive Surgical, Inc.
- Distribuidor
- Worldwide distribution - USA (nationwide) Foreign Distribution to Argentina, Austria, Australia, Belgium, Brazil, Bulgaria, Canada, China, Chile, Czech Republic, Denmark, Finland, France, Germany, Cyprus- Greece, Egypt, Guadeloupe, Israel, Ireland, India, Indonesia, Italy, Japan, Kuwait, Lebanon, Malaysia, Mexico, Monaco, Netherlands, New Zealand, Norway, Pakistan, Philippines, Portugal, Poland, Qatar, Russia, Romania, Slovenia, South Korea, Spain, Sweden, Switzerland, Thailand, Taiwan, Turkey, United Kingdom, Saudi Arabia, Singapore, South Korea, and Venezuela.
- Lote
- Model Numbers 420179-09 and -10 and 400179-09 and -10.
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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