Events

Rappel de Device Recall da Vinci Harmonic ACE

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
    70275
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1118-2015
  • Date de mise en oeuvre de l'événement
    2015-01-21
  • Date de publication de l'événement
    2015-02-13
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-06-01
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132750
  • 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
    Internal labeling review found that the ifu for the harmonic ace incorrectly instructs the user on how to manually open the grips.
  • Action
    A Field Safety Notice entitled, Urgent Medical Device Correction, and dated, January 21, 2015, were sent to customers. The letter identified the problem and the reason for the recall as well as the risk to health. Customers are asked to ensure that all affected personnel are informed of the notice. Additionally, customers are to discard their current Harmonic Ace IFUs. Customers are to refer to the specified manual, reference guide, and instruction card mentioned in the letter. A copy of the notice is to be retained with the da Vinci Standard, S or Si user manual. Intuitive Surgical will remove the Harmonic ACE IFU from all future shipments of the product. Representatives will be available by phone to answer questions related to the Correction.

Device

Device Recall da Vinci Harmonic ACE
  • Modèle / numéro de série
    PN 400275, 420275, and 420272.
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -- US, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Czech Republic, Denmark, Dominican Republic, Ecuador, Finland, France, Germany, India, Israel, Italy, Japan, Lebanon, Mexico, Monaco, Netherlands, Pakistan, Panama, Puerto Rico, Qatar, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, and the United Kingdom.
  • Description du dispositif
    HARMONIC ACE Curved Shears Instructions for Use, 8MM, IS2000/IS3000; for use with the da Vinci Surgical System - IS2000 and IS3000. || Intended for soft tissue incisions when bleeding control and minimal thermal injury are desired. It is used in conjunction with the da Vinci Surgical System
  • 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