Events

Rappel de NEPTUNE ROVER

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par STRYKER CANADA LP.

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
    43709
  • Classe de risque de l'événement
    I
  • Date de mise en oeuvre de l'événement
    2012-05-14
  • 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 stryker neptune waste management system is intended to be used in the operating room pathology surgical centers and doctor's offices to collect and dispose of surgical fluid waste as well as to collect smoke generated from electrocautory or laser devices. stryker instruments was made aware was made aware through informal reports from hospital personnel that a death had occurred and possibly related to use of a neptune rover. the root cause of the problem was confirmed not to be caused by a product malfunction or the result of a non-conformance but rather the event resulted due to a use error.

Device

NEPTUNE ROVER
  • Modèle / numéro de série
    Model Catalog: 0702-001-000 (Lot serial: ALL); Model Catalog: 0700-007-000 (Lot serial: ALL); Model Catalog: 0700-001-000 (Lot serial: ALL); Model Catalog: 0700-003-000 (Lot serial: ALL)
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Description du dispositif
    IFU FOR NEPTUNE WASTE MANAGEMENT SYSTEM
  • Manufacturer
    STRYKER CANADA LP

Manufacturer

STRYKER CANADA LP
  • Adresse du fabricant
    HAMILTON
  • Société-mère du fabricant (2017)
    Stryker
  • Source
    HC