Events

Retiro De Equipo (Recall) de Device Recall MICROVASIVE GOLD PROBE

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 Boston Scientific Corporation.

¿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
    50697
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0978-2009
  • Fecha de inicio del evento
    2008-12-24
  • Fecha de publicación del evento
    2009-02-13
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-05-11
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=76169
  • 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
    Unit, electrosurgical, endoscopic (with or without accessories) - Product Code KNS
  • Causa
    Packaging tray for the gold probe single-use bipolar electrohemostasis catheters may have a crack. cracks in the tray or damage to the tray of the gold probe device may lead to a compromised sterile barrier.
  • Acción
    A notification letter (dated December 24, 2008) was issued to customers. The letter identified the issue. Consignees are instructed to: 1) Discontinue use and segregate affected product, 2) Complete a Reply Verification Tracking Form and fax to the Boston Scientific Corporation (BSC) at 508-683-5578 and 3) Package and ship recalled product as instructed in the letter. If affected product is found, customers are instructed to call BSC Customer Service at 1-866-868-4004 between 8:30 a.m. through 6:00 p.m. (Eastern Standard Time). Please direct questions about the recall to your local Sales Representative.

Device

Device Recall MICROVASIVE GOLD PROBE
  • Modelo / Serial
    Lot Numbers for UPN M00560100: 9261338, 9283882, 9305162, 9327239, 9369045, 9372244, 9412852, 9451457, 9505237, 9521511, 9592459, 9633852, 9681234, 9722306, 9753577, 9754934, 9754935, 9754936, 9810372, 9824002, 11015389, 11036295, 11057651, 11083694, 11147192, 11204692, 11229075, 11263907, 11320518, 11357567, 11390523, 11394227, 11463699, 11525430, 11544096, 11595300, 11617465, 11661744, 11696754, 11742585, 11767910, 11815749, 11871189, 11899606, 11975822, 12027023 and 12051845.  Lot Numbers for UPN M00560101: 9256060, 9356184, 9473937, 9562330, 9644511, 9774420, 11043881, 11132563, 11194002, 11284265, 11324380, 11460248, 11573667, 11624658, 11716593, 11830799, 11979368 and 12030396.
  • Clasificación del producto
    Gastroenterology-Urology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution.
  • Descripción del producto
    Gold Probe 10FR Working Length: 300 cm, Probe Tip O.D. 3.2 mm (10Fr), Rx Only. Electrical Connector: Standard. For Single Use Only. Legal Manufacturer, Boston Scientific Corporation, One Boston Scientific Place Natick, MA 01760-1537 USA. Made in USA: 8600 N.W. 41st Street Miami, FL 33166-6202 USA. || The device is indicated for use in transendoscopic electrocautery of visible bleeding and nonbleeding sites in the gastrointestinal tract including the esophagus, stomach, duodenum, and colon.
  • Manufacturer
    Boston Scientific Corporation

Manufacturer

Boston Scientific Corporation
  • Dirección del fabricante
    Boston Scientific Corporation, 8600 Nw 41st St, Miami FL 33166-6202
  • Empresa matriz del fabricante (2017)
    Boston Scientific
  • Comentario del fabricante
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    USFDA