Events

Retiro De Equipo (Recall) de daVinci EndoWrist(R) Stapler 45

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 Intuitive Surgical, 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
    78908
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0404-2018
  • Fecha de inicio del evento
    2017-09-19
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=160837
  • 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
    System,surgical,computer controlled instrument - Product Code NAY
  • Causa
    Specific da vinci xi endowrist stapler 45 instruments are potentially impacted by a variation in the manufacturing process. in affected instruments, there is a possibility that the stapler release kit (srk) wrench interface feature accessed through release hole 2 is manufactured to an incorrect dimension, which may prevent the srk wrench from being able to manually unclamp the instrument.
  • Acción
    The firm initiated their recall by email on 09/19/2017 and followed with a letter delivered by FedEx on 09/20/2017. The notice requested the following actions: "Please take the following actions to ensure all affected personnel are fully informed of this Field Safety Notice. Forward this letter to your Risk Manager, OR Director, Purchasing, Biomedical Engineering staff, and other members of your medical staff who are involved with da Vinci procedures. 1.Using the lot numbers listed above, please locate and return all affected Staplers at your site via the standard RMA process. a. Credit will be provided for remaining uses on affected instruments returned to Intuitive Surgical. 2.Please log into the da Vinci Online Community field action resource to read and/or complete any requested actions related to this issue. a. https://www.davincisurgerycommunity.com/ 3.If you cannot access the da Vinci Online Community field action resource, please complete the attached Acknowledgement Form and return it via fax or email to Intuitive Surgical per the instructions contained in the Acknowledgement Form. 4.Please retain a copy of this letter and a copy of the Acknowledgement Form for your files."

Device

daVinci EndoWrist(R) Stapler 45
  • Modelo / Serial
    UDI 00886874112427: Serial Numbers: S10170630, S11170705, S10170707, S10170731
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Nationwide Distribution
  • Descripción del producto
    daVinci X EndoWrist(R) Stapler 45, REF 470298 || Product Usage: || The Intuitive Surgical EndoWrist Stapler 45, Stapler 45 Reloads, and other Stapler Accessories (including the bladeless obturators) are intended to be used with the da Vinci Surgical System (Model IS4000) for resection, transection, and/or creation of anastomoses in General, Thoracic, Gynecologic and Urologic surgery. The device can be used with the same staple line or tissue buttressing material (natural synthetic).
  • Manufacturer
    Intuitive Surgical, Inc.

Manufacturer

Intuitive Surgical, Inc.
  • Dirección del fabricante
    Intuitive Surgical, Inc., 1266 Kifer Rd Bldg 101, Sunnyvale CA 94086-5304
  • Empresa matriz del fabricante (2017)
    Intuitive Surgical Inc
  • Source
    USFDA