Events

Retiro De Equipo (Recall) de Device Recall Endoscope Clip applier, Implantable Fastener and Accessories

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 Endogastric Solutions 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
    64395
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1136-2013
  • Fecha de inicio del evento
    2013-02-04
  • Fecha de publicación del evento
    2013-04-17
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-07-02
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116023
  • 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
    Endoscopic suture/plication system, gastroesophageal reflux disease (gerd) - Product Code ODE
  • Causa
    Esophyx2plus device was not validated under actual or simulated use conditions prior to distributing the product to physicians.
  • Acción
    EndoGastric Solutions, Inc. sent an Urgent Medical Device Recall letter dated January 31, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to segregate and record lot numbers for any affected product. If no product remain in inventory customers were instructed to report such to customer service. Upon receipt of the product a credit will be issued for each device returned. For any questions customers were instructed to call 425-307-9226. For questions regarding this recall call 425-307-9200.

Device

Device Recall Endoscope Clip applier, Implantable Fastener and Accessories
  • Modelo / Serial
    Lots 401378, 401392, 401409, and 401416 Additional lots manufactured from 11/26/12 to 12/07/12 had a stop ship issued issued on 11/21/12 and the product was placed in quarantine (it was not distributed). This represents an additional 175 units from a total of 187 units manufactured during this time period. 12 units were used for bench testing. The lot numbers of units in quarantine are 401432, 401434, 401436, and 401441.
  • Clasificación del producto
    Gastroenterology-Urology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Nationwide Distribution including NC, VA, WI, TN, KY, IN, FL, MI, IA, IL, TX, LA, AR, HI, CA, NV, OR, and WA,
  • Descripción del producto
    EndoGastric Solutions EsophyX2 Plus Device with Serosa Fastener and Accessories Part number C02033-01. Label reads in part "EsophyX2 2-LINK Device Qty: (1) Fastener Delivery System ***" || Designed for the treatment of Gastroesophageal Reflux Disease (GERD), with erosive and non-erosive esophagitis
  • Manufacturer
    Endogastric Solutions Inc

Manufacturer

Endogastric Solutions Inc
  • Dirección del fabricante
    Endogastric Solutions Inc, 8210 154th Ave NE, Redmond WA 98052-3877
  • Empresa matriz del fabricante (2017)
    Endogastric Solutions Inc
  • Source
    USFDA