Events

Retiro De Equipo (Recall) de Device Recall EndoWrist One Vessel Sealer, 8MM, IS4000

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
    70467
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1142-2015
  • Fecha de inicio del evento
    2015-02-11
  • Fecha de publicación del evento
    2015-02-24
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-06-01
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=133843
  • 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
    Intuitive surgical has identified the potential for a certain, small portion of vessel sealers to exhibit interference in the back of the instrument grips due to manufacturing variability in some jaws.
  • Acción
    Intuitive Surgical sent an Urgent Medical Device Correction letter dated Feruary 11, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to take the following actions: 1. Forward this letter to any members of your medical staff who perform da Vinci procedures in addition to your Risk Manager, OR Director, Purchasing and Biomedical Engineering staff. 2. This field correction does not require you to quarantine or return the affected devices. Vessel Sealers can continue to be used safely by adhering to the following guidelines as provided in the Vessel Sealer User Manual: a. Only procedures that incorporate sealing and transection of thin tissue bundles and small diameter vessels are affected by this issue. Prior to the procedure, determine whether this issue may be a factor and choose whether or not to use the device per the following instructions. Alternative methods of sealing and transection are described below. b. During sealing, always inspect tissue for energy effect (i.e. blanching, steam, bubbling) along the entire jaw of the instrument. While audio tones designate seal cycle completion, tissue effect should always be seen prior to proceeding to cut. If no tissue effect is seen, then DO NOT CUT. Re-grasp tissue and re-attempt sealing as described above. If the issue persists, the instrument may be affected and an alternative means of sealing and transecting thin vascular tissue bundles should be used. These other methods include using another da Vinci Vessel Sealer, alternative da Vinci electrosurgical instruments, a da Vinci Harmonic instrument or hand-held laparoscopic sealing device. 3. Complete the attached Acknowledgement Form and return it to Intuitive Surgical as instructed. 4. Please retain a copy of this letter and the Acknowledgement Form for your files. 5. If you choose to not continue to use affected Vessel Sealer instruments, you may retu

Device

Device Recall EndoWrist One Vessel Sealer, 8MM, IS4000
  • Modelo / Serial
    PN 480322-04, Lot numbers: S10140730 S10140904 S10141007 S10141103 S10140805 S10140912 S10141009 S10141111 S10140814 S10140916 S10141015 S10141118 S10140824 S10140923 S10141020 S10141125 S10140827 S10141001 S10141028.
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) and Internationally to Australia, Belgium, China, Denmark, Ecuador, Finland, France, Germany, Greece, Italy, Netherlands, Norway, Puerto Rico, Saudi Arabia, South Korea, Spain, Sweden, Switzerland, Turkey, and United Kingdom.
  • Descripción del producto
    EndoWrist One Vessel Sealer, 8MM, IS4000, 6 pack used in conjunction with the da Vinci Surgical System Xi IS4000. || The EndoWrist Vessel Sealer is a bipolar electrosurgical instrument for use with the da Vinci Xi Surgical System and the ERBE VIO dV electrosurgical generator. It is intended for grasping and blunt dissection of tissue and for bipolar coagulation and mechanical transection of vessels up to 7 mm in diameter and tissue bundles that fit in the jaws of the instrument.
  • Manufacturer
    Intuitive Surgical, Inc.

Manufacturer

Intuitive Surgical, Inc.
  • Dirección del fabricante
    Intuitive Surgical, Inc., 1266 Kifer Rd Bldg 100, Sunnyvale CA 94086-5304
  • Empresa matriz del fabricante (2017)
    Intuitive Surgical Inc
  • Source
    USFDA