Events

Retiro De Equipo (Recall) de Device Recall EnSeal TRIO

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
    56292
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2635-2010
  • Fecha de inicio del evento
    2010-07-09
  • Fecha de publicación del evento
    2010-09-30
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-02-14
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=93674
  • 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
    Laparoscope, general; plastic surgery, reprocessed - Product Code NLM
  • Causa
    The weld that connects the electrode to the active rod was separated. this connection is critical to the proper function of these devices. if the weld is separated, the product will not deliver energy to the jaws, resulting in the potential for a cut/transection without a seal. ethicon endo-surgery identified this issue during a routine finished goods quality inspection.
  • Acción
    Ethicon Endo-Surgery issued an Urgent: Device Recall, Event 2193 letter dated July 19, 2010 identifying the affected device, the issue prompting the recall, and actions to be taken by consignees. Consignees were instructed: Do not use the affected product. Identify and quarantine affected product from inventory. Complete the Business Reply form and fax to Stericycle at 877-597-9580 within three days To return product, place it in a box with a copy of the Business Reply form and mail to Stericycle using the pre-printed UPS shipping label. Replacement product should be received by the customer within 60 days of return of affected product. Customers can contact Stericycle about this recall at 877-243-7314 and referencing Event 2193.

Device

Device Recall EnSeal TRIO
  • Modelo / Serial
    Product Code ETRIO335H, Lot Code: G4TC14, Exp. Date 2012/05
  • Clasificación del producto
    Gastroenterology-Urology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution to the following states: AZ, AL, AZ, CA, CO, CT, FL, GA, IN, KY, MA, MD, MI, MO, MS, NC, NV, NY, OH, PA, TN, TX, WA, and WV.
  • Descripción del producto
    Enseal¿ TRIO Product Code ETRIO335H, Lot Code: G4TC14, Exp. Date 2012/05
  • 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