Events

Rappel de Device Recall da Vinci Xi" 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
    69638
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0429-2015
  • Date de mise en oeuvre de l'événement
    2014-11-03
  • Date de publication de l'événement
    2014-11-25
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-02-03
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=131214
  • 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
    Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface degradation of the housing and/or accelerate mechanical wear of the instrument.
  • Action
    Urgent Medical Device Recall letters were sent to affected sites on November 3, 2014. Letters inform customers of the reason for recall, risk to health and the affected instrument. A table of all of the affected IS4000 instruments affected is attached to the letter indicating the part number and product name for each. Letters also inform customers that all instruments shipped since July 2014 are manufactured with a new material and not subject to recall. Customers are to take the following actions: 1. Ensure that all affected personnel are aware of the information. 2. Identify affected product in their possession 3. Contact ISI rep for replacement. 4. Complete and return the attached Acknowledgement From. Until replacement instruments are received, the old instruments may be used provided they do not show signs of degradation and that the reprocessing instructions are followed. Questions to 800-876-1310 Option 3 ( 6 am to 5 pm PST) or ics@intusurg.com.

Device

Device Recall da Vinci Xi" Surgical System
  • Modèle / numéro de série
    Part number: 470033-04; All 8mm da Vinci Xi (IS4000) Surgical System instruments manufactured with white colored housings.
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US Distribution -- FL, TX, NY, NV, OR, IN, UT, and MA.
  • Description du dispositif
    8MM,BLACK DIAMOND MICRO FORCEPS; || Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
  • 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