Events

Retiro De Equipo (Recall) de Device Recall PKG, BABCOCK FORCEPS

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-0684-2015
  • 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=131752
  • 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, BABCOCK FORCEPS
  • Modelo / Serial
    140571 140572 140590 442506 542896 643523 646838 741305 741307 744923 842628 842632 842638 842640 847869 847870 847872 847873 847877 847878 847880 847881 847885 847886 1041276 1042935 1042951 1045190 1046166 1046900 1046901 1140664 1140821 1142174 1142665 1143446 1143728 1144692 1145109 1146164 1146165 1146388 1146900 1146901 1147163 1240407 1240955 1241953 1241954 1242409 1243807 1244132 1244241 1244441 1245480 1246060 1246405 1340290 1341254 1341835 1341836 1343535 1343993 1346493 1440592 1440788 1440789
  • 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, BABCOCK FORCEPS, P/N 0250080321. || 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