Events

Rappel de CONICAL TIP SPIKE

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par OLYMPUS CANADA 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
    28492
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2010-02-09
  • 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
    The manufacturer has received one complaint that the trocar tip had fallen off during a surgical procedure. as a consequence the tip needed to be removed in an additional surgical procedure. the trocar tip was detached from the trocar shaft due to a fracture in the weld seam between the tip and shaft.

Device

CONICAL TIP SPIKE
  • Modèle / numéro de série
    Model Catalog: A5949 (Lot serial: 084W); Model Catalog: A5821 (Lot serial: 075W); Model Catalog: A5949 (Lot serial: 081W); Model Catalog: A5949 (Lot serial: 07YW); Model Catalog: A5949 (Lot serial: 07XW); Model Catalog: A5949 (Lot serial: 078W); Model Catalog: A5949 (Lot serial: 077W); Model Catalog: A5949 (Lot serial: 076W); Model Catalog: A5949 (Lot serial: 075W); Model Catalog: A5948 (Lot serial: 081W); Model Catalog: WA58341L (Lot serial: 081W); Model Catalog: A5821 (Lot serial: 081W); Model Catalog: A5948 (Lot serial: 07YW); Model Catalog: WA58341L (Lot serial: 07YW); Model Catalog: A5821 (Lot serial: 07YW); Model Catalog: A5948 (Lot serial: 07XW); Model Catalog: WA58341L (Lot serial: 07XW); Model Catalog: A5821 (Lot serial: 07XW); Model Catalog: A5948 (Lot serial: 078W); Model Catalog: WA58341L (Lot serial: 078W); Model Catalog: A5821 (Lot serial: 078W); Model Catalog: A5948 (Lot serial: 077W); Model Catalog: WA58341L (Lot serial: 077W); Model Catalog: A5821 (Lot serial: 077W); Model Catalog: A5948 (Lo
  • Description du dispositif
    OLYMPUS TROCAR SPIKES (CONICAL TIP)
  • Manufacturer
    OLYMPUS CANADA INC.

Manufacturer

OLYMPUS CANADA INC.