Events

Rappel de PenAdapt(an aspiration sheath that fits over an electrosurgical pencil body and leaves the tip or blade exposed)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Stryker Australia Pty Ltd.

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
    RC-2015-RN-00422-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-05-18
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00422-1
  • Notes / Alertes
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notes supplémentaires dans les données
  • Cause
    During packaging verification testing, a breach in the sterile barrier was observed in some of the units tested. additional testing identified microscopic aluminium metal shavings and foreign particles estimated in size to be between 0.01inches x 0.015 inches to 0.03 inches x 0.04 inches in some of the units tested. it was determined that these particles were introduced during the manufacturing process and were sterilised within the tyvek pouch with the product. the potential hazards of this product issue include patient exposure to infectious material, potentially leading to patient infection, and patient exposure to sterile foreign material potentially leading to foreign body inflammation.
  • Action
    Customers are asked to check any PenAdapt items in their possession and quarantine any affected units immediately. A Stryker Representative will contact customers to coordinate an inspection of the affected items in quarantine. Any affected items will be removed by the Stryker Representative and a credit will be issued to the customer account. Stryker is also requesting the customers to review the patient records for issues that may have been associated with the use of the affected device, such as infection and/or inflammation.

Device

PenAdapt(an aspiration sheath that fits over an electrosurgical pencil body and leaves the tip or...
  • Modèle / numéro de série
    PenAdapt(an aspiration sheath that fits over an electrosurgical pencil body and leaves the tip or blade exposed)Item number: 0702045027Multiple lot numbersARTG Number: 171568
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

Stryker Australia Pty Ltd
  • Société-mère du fabricant (2017)
    Stryker
  • Source
    DHTGA