Events

Rappel de URETERO-RENO FIBERSCOPE

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
    71582
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2016-12-22
  • 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 olympus medical systems corp (omsc) has initiated this corrective action following complaints on the urf-p6/p6r insertion tube and breaks of the bending tube. these complaints have not resulted in any known adverse event. the urf-p6/p6r endoscopes are intended for use in endoscopic diagnosis and treatment within the ureter kidney and biliary tract (common bile duct and hepatic duct). omsc is aware of adverse events on the urf-v2/v2r endoscopes which have a similar structure to the urf-p6/p6r endoscopes. olympus is providing a two-page instructions for safe use to remind customers of inspection instructions in the existing operation manual and also provide pictures and instructions to assist in performing the inspection.

Device

URETERO-RENO FIBERSCOPE
  • Modèle / numéro de série
    Model Catalog: URF-P6 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: URF-P6R (Lot serial: ALL SERIAL NUMBERS)
  • Description du dispositif
    URETERO-RENO FIBERSCOPE
  • Manufacturer
    OLYMPUS CANADA INC.

Manufacturer

OLYMPUS CANADA INC.