Events

Rappel de Device Recall da Vinci S and Si Surgical System

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Intuitive Surgical, Inc..

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    71285
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1812-2015
  • Date de mise en oeuvre de l'événement
    2015-05-21
  • Date de publication de l'événement
    2015-06-17
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2018-07-02
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=137239
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    System,surgical,computer controlled instrument - Product Code NAY
  • Cause
    The coating of the 5 mm thoracic grasper main tube may experience damage with the possibility of fragments of coating material dislodging and potentially falling into patient.
  • Action
    Urgent Medical Device Recall letters were sent to all consignees on May 21, 2015. The letter describes the affected product and issue involved. Additionally, the risk to health, as well as the actions to be taken were also discussed in the letter. Customers are to ensure that all affected personnel were informed of the notice. All affected product are to be identified and returned by contacting Customer Service for a RMA. The Acknowledgment Form is to be completed and returned using the instructions provided. If further information or support concerning this recall is needed, customers are to contact their local Clinical Sales Representative or Intuitive Surgical Customer Service.

Device

Device Recall da Vinci S and Si Surgical System
  • Modèle / numéro de série
    version 420343-01 and 420323-02, all lots
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -- US, Belgium, Brazil, Canada, Chile, Colombia,, Denmark, France, Germany, India, Netherlands, Panama, Singapore, South Korea, Switzerland, Taiwan, Turkey, and United Kingdom.
  • Description du dispositif
    Thoracic Grasper, 5 MM, for use with da Vinci S (IS2000) and SI (IS3000) Surgical Systems. || Intended for endoscopic manipulation of tissue, including grasping.
  • Manufacturer
    Intuitive Surgical, Inc.

Manufacturer

Intuitive Surgical, Inc.
  • Adresse du fabricant
    Intuitive Surgical, Inc., 1266 Kifer Rd Bldg 100, Sunnyvale CA 94086-5304
  • Société-mère du fabricant (2017)
    Intuitive Surgical Inc
  • Source
    USFDA