Events

Retiro De Equipo (Recall) de Device Recall MicroCutter XCHANGE 30

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 Cardica, 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
    72687
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0482-2016
  • Fecha de inicio del evento
    2015-11-06
  • Fecha de publicación del evento
    2015-12-24
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-02-12
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=141981
  • 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
    Staple, implantable - Product Code GDW
  • Causa
    Cardica, inc. has received reports that use of the blue cartridges with the microcutter xchange 30 stapler was associated with incomplete firing of staples, potentially resulting in an incomplete transection or anastomosis of tissue during the surgical procedure.
  • Acción
    An Urgent: Medical Device Removal letter, dated November 17, 2015, was sent via Fed Ex. The letter identified the affected device, described the reason for the recall, and provided the instructions to be followed. Customers were asked to check their inventory, and remove and quarantine any affected product. The notice should be forwarded to relevant personnel, and the affected product should be returned along with the completed Reply Form. A credit will be issued for any returned product. A sales representative can be contacted with questions.

Device

Device Recall MicroCutter XCHANGE 30
  • Modelo / Serial
    Lot numbers: 120416D 120521E 120606F 120613B 120621A 120910A 120926H 121005C 121022A 121031A 121119B 121217F 130131A 130207A 130213A 130220H 130227C 130307B 130320A 130328A 130426A 130508A 130516A 130619B 130613H 130716C 130815E 130822C 130911C 131003E 131113C 131125D 131212F 140109F 140115D 140127B 140204B 140226J 140304A 140310K 140317B 140325B 140430C 140507B 140604C 140610E 140617H 140624E 140707G 140710D 140715H 140804D 140819B 140828C 140916E 140922C 140926C 141008E 141016E 141103A 141106A 150415D 150625B 150813B 151006G
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution -- USA, distributed to the states of Alabama, California, Colorado, Florida, Georgia, Iowa, Massachusetts, Maryland, Minnesota, New York, Ohio, Pennsylvania, Rhode Island, Texas, Washington, and Wisconsin ; and, to the countries of Austria, Belgium, France, Germany, Ireland, Italy, Luxembourg, Netherlands and United Kingdom, Switzerland, and Qatar.
  • Descripción del producto
    MicroCutter Xchange 30 Blue Cartridge, FG-025320; || The MicroCutter XCHANGE 30 Blue Cartridge and MicroCutter XCHANGE 30 Blue Curved Tip Cartridge contain 316L stainless steel staples. The cartridges are used with the MicroCutter XCHANGE 30 Stapler, which is a single patient device. When the MicroCutter XCHANGE 30 Stapler is loaded with a MicroCutter XCHANGE 30 Cartridge, two double rows of 316L stainless steel staples are delivered while simultaneously transecting tissue between the two, double staple rows. The MicroCutter XCHANGE 30 Stapler and MicroCutter XCHANGE 30 Cartridge are designed for introduction and use through a 5mm trocar cannula or larger. || Intended for use in multiple open or minimally invasive surgical procedures for the transaction, resection, and /or creation of anastomoses in small and large intestine as well as the transection of the appendix.
  • Manufacturer
    Cardica, Inc.

Manufacturer

Cardica, Inc.
  • Dirección del fabricante
    Cardica, Inc., 900 Saginaw Dr, Redwood City CA 94063-4753
  • Source
    USFDA