Events

Rappel de DA VINCI SURGICAL SYSTEM DRAPE

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
    80214
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2015-04-20
  • 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
    Tears: through standard product quality testing it was noted that the adhesive labels intended to keep the drape folded were found in some instance unintentionally overlapping multiple folds of the drape. cloudy/waxy appearance: through customer feedback intuitive surgical found that some of the drapes used with the da vinci systems may exhibit a cloudy/waxy appearance.

Device

DA VINCI SURGICAL SYSTEM DRAPE
  • Modèle / numéro de série
    Model Catalog: 420258-01 (Lot serial: > 10 lot numbers contact Mfg); Model Catalog: 420273-02 (Lot serial: > 10 lot numbers contact Mfg); Model Catalog: 420022-02 (Lot serial: > 10 lot numbers contact Mfg); Model Catalog: 420015-03 (Lot serial: > 10 lot numbers contact Mfg); Model Catalog: 420026-01 (Lot serial: > 10 lot numbers contact Mfg); Model Catalog: 420291-03 (Lot serial: > 10 lot numbers contact Mfg); Model Catalog: 420017-03 (Lot serial: >10 numberscontact mfg); Model Catalog: 400027-04 (Lot serial: >10 numberscontact mfg); Model Catalog: 400016-04 (Lot serial: >10 numberscontact mfg); Model Catalog: 400015-03 (Lot serial: >10 numberscontact mfg); Model Catalog: 420290-03 (Lot serial: >10 numberscontact mfg); Model Catalog: 420279-03 (Lot serial: >10 numberscontact mfg); Model Catalog: 420281-02 (Lot serial: >10 numberscontact mfg); Model Catalog: 420273-02 (Lot serial: >10 numberscontact mfg); Model Catalog: 420258-01 (Lot serial: >10 numberscontact mfg); Model Catalog: 420256-01 (Lot serial: >10
  • Description du dispositif
    Da Vinci Surgical System Drape
  • Manufacturer
    MINOGUE MEDICAL INC.

Manufacturer

MINOGUE MEDICAL INC.