Events

Retiro De Equipo (Recall) de Device Recall SPIDER ADVANCED Surgical Platform

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 Transenterix, 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
    58093
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1910-2011
  • Fecha de inicio del evento
    2011-02-25
  • Fecha de publicación del evento
    2011-04-08
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-11-07
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=98333
  • 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 - Product Code GCJ
  • Causa
    Plastic shards may break off and fall into the abdominal space which may require retrieval during surgery.
  • Acción
    TransEnterix sent an Urgent Device Recall letter dated February 25, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to check their inventory for the lot numbers affected, complete the attached inventory reconciliation form and return the form, along with any affected product to TransEnterix using the enclosed shipping label. Customers were asked to return the inventory form even if they had none of the lot numbers affected in their inventory. Their sales representative and customer service will work with them to replace the product in full at not cost to them. For questions regarding this recall contact TransEnterix Customer Care at 1-888-879-4111.

Device

Device Recall SPIDER ADVANCED Surgical Platform
  • Modelo / Serial
    Model number: 9000021, Lot numbers: TRX056201001,  TRX061201002, TRX071201001, TRX086201003.
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution including AZ, FL, NC, NY, OH, OR, SC, TX, VA and WA
  • Descripción del producto
    SPIDER ADVANCED Surgical Platform || The SPIDER is a single port, single incision device to facilitate multi-instrument access during laparoscopic surgical procedures. The SPIDER device is provided pre-sterilized and is a single use device.
  • Manufacturer
    Transenterix, Inc

Manufacturer

Transenterix, Inc
  • Dirección del fabricante
    Transenterix, Inc, 635 Davis Dr Ste 300, Morrisville NC 27560-7183
  • Empresa matriz del fabricante (2017)
    Transenterix Inc.
  • Source
    USFDA