Events

Retiro De Equipo (Recall) de Device Recall PKG, 5MM PEEK HANDLE, 45CM

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 Stryker Endoscopy.

¿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
    69838
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0757-2015
  • Fecha de inicio del evento
    2014-11-17
  • Fecha de publicación del evento
    2014-12-12
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-07-17
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=131843
  • 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
    Endoscope and/or accessories - Product Code KOG
  • Causa
    The parameters provided in the laparoscopic manual instruments instructions for use (ifu 1000-401-070 revision g or prior) do not support the unwrapped gravity cycle and the ethylene oxide cycle sterilization methods.
  • Acción
    Stryker Endoscopy sent an Urgent Device Correction letter dated November 17, 2014, to affected customers. The letter informed the customers of the potential hazards and actions required. Customers were instructed to discard any old Instructions for Use for their Laparoscopic Manual Instruments and Accessories. Download the new Instuctions for Use (IFU1000-401-070 Revision J) from the URL link below: www.stryker.com/IFU1000401070 Customers were instructed to complete and sign the enclosed "Acknowledgement of Receipt" form and email them to endorecall@stryker.com or fax to (408) 855-6314. Customers with questions were instructed to contact Stryker Endoscopy at 408-855-6238 or via email at endorecall@stryker.com. For questions regarding this recall call 408-754-2000.

Device

Device Recall PKG, 5MM PEEK HANDLE, 45CM
  • Modelo / Serial
    01292013D 0247065C 0341845C 0342941C 0345124C 0345125C 4082014 0540391C 0540392CD 0542893D 0647218D 07122013E 0743480D 0744062D 0843047D 0845027D 0845859D 0846783D 0940144D 0940148D 0940821D 0941601D 0943110D 0943251D 0943541D 0944721D 0945231D 0945465D 1040630D 1040806D 1041063D 1041468D 1042102D 1043037D 1043039D 1044650D 1045037D 1045055D 1045227D 1045481D 1045638D 1045841D 1046702D 11082010A 1141562 1141562D 1141969D 1141970D 1142168D 1143113D 1143150D 1144236D 1144341D 1144655D 1145341D 1145632D 1145809D 1145939 1145939D 1146669D 1146671D 12122013 1241797D 1241938D 1243268D 1243269D 1244956 1244956D 1245522 1245798 1245799 1245799H 1245800 1245977 1340938 1341257 1341872 1343540 1343540H 1343541 1343542 1344000 1344000H 1344251 1440346 1440346H 1440347 1440347H 1440792 1442304 1442799
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) and Internationally to Algeria, Argentina, Australia, Bolivia, Brazil, Canada, Chile, China, Colombia, Costa Rica, Ecuador, France, Germany, Greece, Guam, Guatemala, India, Italy, Japan, Jordan, Kuwait, Latin America, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Saudi Arabia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom, and Venezuela.
  • Descripción del producto
    PKG, 5MM PEEK HANDLE, 45CM, P/N 0250181164 || Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.
  • Manufacturer
    Stryker Endoscopy

Manufacturer

Stryker Endoscopy
  • Dirección del fabricante
    Stryker Endoscopy, 5900 Optical Ct, San Jose CA 95138-1400
  • Empresa matriz del fabricante (2017)
    Stryker
  • Source
    USFDA