Events

Rappel de TIP COVER ACCESSORY

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada 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
    130149
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2012-08-09
  • Pays de l'événement
    Canada
  • Source de l'événement
    HC
  • Notes / Alertes
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Notes supplémentaires dans les données
  • Cause
    During the manufacturing process to package each tip cover each part is placed into the top open end of a rectangular pre-made pouch which is sealed along the sides and bottom edges. to seal the pouch containing the product the open end edge is clamped and sealed by applying heat and pressure creating a closed seal impressed with a thatched pattern. it has been found with a small number of the pouches manufactured when creating the closure the sealed edge was not uniform and pleats or creases were formed within the seal area of the pouch. of those non-uniform seals in a small percentage of these seals these pleats or creases may breach the seal barrier integrity.

Device

TIP COVER ACCESSORY
  • Modèle / numéro de série
    Model Catalog: 400180 (Lot serial: Contact manufacturer.); Model Catalog: 400180 (Lot serial: >10 lot numbers.)
  • Description du dispositif
    8MM Tip Cover Accessory
  • Manufacturer
    INTUITIVE SURGICAL INC.

Manufacturer

INTUITIVE SURGICAL INC.