Events

Retiro De Equipo (Recall) de Gyrus ACMI Reusable Active Cord for Bovie/ValleyLab Generators

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Gyrus Acmi, Incorporated.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    79762
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1952-2018
  • Fecha de inicio del evento
    2018-04-17
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=163258
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Electrode, electrosurgical, active, urological - Product Code FAS
  • Causa
    There is a potential for the cord to spark and cause a fire.
  • Acción
    Notification letters were distributed on April 17, 2018. The letters instruct customers to perform the following: Immediately assess any affected product you have in stock and replace the IFU with the revised IFU. Also ensure that any potential users of the devices are aware of the additional warning in the revised IFU. Future versions of the IFU will include the warning. Remove and discard all cords in use greater than one year. If you need additional copies of the IFU, call your Olympus customer service representative at 1-888-524-7266 to arrange for them to be provided. Please note on the enclosed Reply Form that you have received this information. Fax the completed Reply Form to 484-896-7128 regardless of whether you have any affected inventory at your facility. In addition, if you may have further distributed this product, please identify your customers, inform them at once of this action, provide the revised IFU and appropriately document your notification process. Your notification to your customers may be enhanced by including a copy of this letter. For further questions, please call (508) 804-2600.

Device

Gyrus ACMI Reusable Active Cord for Bovie/ValleyLab Generators
  • Modelo / Serial
    All lots manufactured before December 7, 2017  UDI (00821925008700)
  • Clasificación del producto
    Gastroenterology-Urology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) Distribution to the states of : AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV, and WY., and to the countries of : Japan, Canada, Mexico, Australia, and EU.
  • Descripción del producto
    Gyrus ACMI Reusable Active Cord for Bovie/ValleyLab Generators, Catalog No C650-129A (00821925008700) || The cord consists of a single conductor stranded wire terminated with plugs that connect to a generator on one end and a plug that connects to a Gyrus ACMI working element on the other end. They are provided non-sterile and are reusable. The cord is designed to be used with Gyrus ACMI GOCUS 640, Bovie, and other general purpose monopolar electrosurgical generators and appropriate electrodes and endoscopes.
  • Manufacturer
    Gyrus Acmi, Incorporated

Manufacturer

Gyrus Acmi, Incorporated
  • Dirección del fabricante
    Gyrus Acmi, Incorporated, 136 Turnpike Rd, Southborough MA 01772-2118
  • Source
    USFDA