Events

Rappel de ULTRA-SOUND SCOPE

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par PENTAX 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
    134836
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2012-02-10
  • 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
    Hoya corporation/pentax life care division has determined that there is a possibility of cross-contamination for the eg-3870utk ultrasound gastroscope under certain conditions. the potential for cross contamination can occur when there is a clog in the balloon suction channel as there is no method to reliably force fluid specifically through the balloon suction channel when following the present cleaning and high-level disinfection procedure. if the channels are not meticulously checked prior to use the clog might not be detected. there are two known ways that a clog can develop: a. if the balloon is not used and fluid is suctioned from the body cavity using the balloon suction channel a clog can develop. (note that using the balloon suction channel to suction fluid from the body is inefficient due to the small size of the channel.) b. if body cavity fluid is suctioned into the balloon suction channel and a clog occurs the clog may be difficult to detect. the device with an undetected clog might be used in a subsequent patient. in the unlikely event that the scope passes the pre-procedure function check and is then used without the balloon the clog could potentially become dislodged and infused into the next patient resulting in the potential for cross contamination.

Device

ULTRA-SOUND SCOPE
  • Modèle / numéro de série
    Model Catalog: EG-3870UTK (Lot serial: >10 NUMBERS CONTACT MFG)
  • Description du dispositif
    PENTAX ULTRASOUND VIDEO GASTROSCOPE
  • Manufacturer
    PENTAX CANADA INC.

Manufacturer

PENTAX CANADA INC.
  • Adresse du fabricant
    MISSISSAUGA
  • Société-mère du fabricant (2017)
    HOYA Corp.
  • Source
    HC