Events

Rappel de DA VINCI SURGICAL SYSTEM (MODEL IS1000)

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par MINOGUE MEDICAL 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
    33058
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2013-08-12
  • 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
    A revised instructions for use (ifu) for reprocessing of da vinci endowrist instruments will be released. these changes have been implemented to ensure customers have clear information related to the use and reprocessing of da vinci instruments and accessories and to assist da vinci customers with compliance to local requirements. the current ifu is still valid. this update improves the process improves the clarity of the instructions themselves and allows for alkaline cleaners and is not being performed for safety issues or the ifu is defective.

Device

DA VINCI SURGICAL SYSTEM (MODEL IS1000)
  • Modèle / numéro de série
    Model Catalog: IS1200 (Lot serial: S00173); Model Catalog: IS1200 (Lot serial: S00150); Model Catalog: IS1200 (Lot serial: S00305); Model Catalog: IS3000 (Lot serial: >10 serial numbers.); Model Catalog: IS3000 (Lot serial: Contact manufacturer.); Model Catalog: IS1200 (Lot serial: S00421); Model Catalog: IS2000 (Lot serial: SG345); Model Catalog: IS2000 (Lot serial: SG242); Model Catalog: IS2000 (Lot serial: SG268); Model Catalog: IS2000 (Lot serial: SG570); Model Catalog: IS2000 (Lot serial: SG431); Model Catalog: IS2000 (Lot serial: SG359)
  • Description du dispositif
    Da Vinci Surgical System (Model IS1000)
  • Manufacturer
    MINOGUE MEDICAL INC.

Manufacturer

MINOGUE MEDICAL INC.