Events

Rappel de Device Recall IS4000 da Vinci Xi Endoscope accessory

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
    68531
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1870-2014
  • Date de mise en oeuvre de l'événement
    2014-06-11
  • Date de publication de l'événement
    2014-06-25
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-07-02
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128147
  • 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
    In some procedures when using the endoscope in conjunction with the is4000 (da vinci xi) system, the surgical view has an orange-yellow tint which can make it hard to differentiate between tissue.
  • Action
    Medical Device Recall notifications were sent to the 4 affected sites on June 11, 2014. Letters describe the problem and the potential health risk. The two model numbers of the endoscope are listed and the statement that ISI will perform a software upgrade to the da Vinci System and replace the endoscopes. Letters request that the following actions take place: - Ensure that all appropriate personnel are fully informed of the information provided in the notification letter. - Complete and return the acknowledgement form using instructions provided. - Retain a copy of The letter for your records. Intuitive representatives will schedule a site visit to provide the re-calibrated endoscope, update the software and ensure that it is properly integrated with the da Vinci Xi Surgical System. Questions or concerns may be directed to Intuitive Customer Service at 800-876-1310.

Device

Device Recall IS4000 da Vinci Xi Endoscope accessory
  • Modèle / numéro de série
    470027-20
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Distributed in the states of FL, TX, and NY.
  • Description du dispositif
    IS4000 da Vinci Xi - Endoscope accessory; || 30 Degree, 8mm Endoscope. || Intuitive Surgical Inc.
  • 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