Events

Retiro De Equipo (Recall) de Device Recall ENSEAL 5 mm Diameter Tissue Sealer G2 14 cm Length Curved Jaw,

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 Ethicon Endo-Surgery Inc.

¿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
    61314
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1244-2012
  • Fecha de inicio del evento
    2012-01-26
  • Fecha de publicación del evento
    2012-03-21
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-02-15
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107789
  • 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
    Electrosurgical, cutting & coagulation & accessories - Product Code GEI
  • Causa
    Ethicon endo-surgery initiated a voluntary global recall for specific production lots of enseal¿ g2 curved and straight tissue sealers due to two potential issues that may occur related to the activation button: (i) continuous activation: the enseal¿ device/system may continue to activate when the activation button is released prior to reaching the end of cycle (tone 3). (ii) no activation.
  • Acción
    Ethicon Endo-Surgery sent an Urgent Medical Device Recall letter dated February 10, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately stop use of the affected product, fill out the attached Business Reply Form (BRF) and return to and return the affected product to: Ethicon Endo-Surgery ATT: ENSEAL G2 Recall 4545 Greek Road Cincinnati, Ohio 45242 Customers were instructed to choose one of the following response options: Return the Business Reply Form to their sales representative Call 1-800-873-3636, Option 6 Fax the BRF to 1-513-337-4138 For any questions regarding this recall call 513-337-3419.

Device

Device Recall ENSEAL 5 mm Diameter Tissue Sealer G2 14 cm Length Curved Jaw,
  • Modelo / Serial
    Product Code 00NSLG2C14, Lot # H44Y2P, Exp Date Nov-2013; Product Code 00NSLG2C25, Lot # H44Z6V, Exp Date Nov-2013 & Lot # J4A16C, Exp Date Dec-2013
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA including AZ, CA, CT, FL, IL, IN, KS, KY, MA, MI, MO, NC, NY, OH, PA, TN & TX and the countries of Arab Emirates, Austria, Belgium, France, Germany, Great Britain, Italy, Jordan, Kingdom of Saudi Arabia, Lebanon, Portugal, Slovenia, Sweden and Turkey.
  • Descripción del producto
    ENSEAL¿ 5 mm Diameter Tissue Sealer G2 14 cm Length Curved Jaw, Model # NSLG2C14 and ENSEAL¿ 5 mm Diameter Tissue Sealer G2 25 cm Length Curved Jaw, Model # NSLG2C25. Ethicon Endo-Surgery, LLC Guaynabo, Puerto Rico 00969 || The ENSEAL¿ G2 Tissue Sealers are indicated for bipolar coagulation and mechanical transection of tissue during laparoscopic and open procedures. The devices are bipolar electrosurgical instruments for use with an electrosurgical generator. They are intended for use during open or laparoscopic, general and gynecological surgery to cut and seal vessels, and to cut, grasp and dissect tissue during surgery. Indications for use include open and laparoscopic, general and gynecological surgical procedures (including urologic, thoracic, plastic and reconstructive, bowel resections, hysterectomies, cholecystectomies, gall bladder procedures, Nissen fundoplication, adhesiolysis, oophorectomies, etc.), or any procedure where vessel ligation (cutting and sealing), tissue grasping and dissection is performed. The devices can be used on vessels up to (and including) 7 mm and bundles as large as will fit in the jaws of the instruments.
  • Manufacturer
    Ethicon Endo-Surgery Inc

Manufacturer

Ethicon Endo-Surgery Inc
  • Dirección del fabricante
    Ethicon Endo-Surgery Inc, 4545 Creek Rd, Cincinnati OH 45242-2803
  • Empresa matriz del fabricante (2017)
    Johnson & Johnson
  • Source
    USFDA