Events

Rappel de Instructions For Use (IFU) - Sonopet Ultrasonic Products

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-2018-RN-00323-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2018-04-19
  • 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-2018-RN-00323-1
  • 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
    The fda has recommended that device manufacturers add the following statement to product labelling for ultrasonic aspirators indicated for laparoscopic, open, or gynaecologic surgery:"contraindication: this ultrasonic surgical aspirator device is not indicated for and should not be used for the fragmentation, emulsification, and aspiration of uterine fibroids."given this, stryker is updating the ifu to include this for all sonopet ultrasonic products. all sonopet ultrasonic products manufactured after march 30, 2018 will include an already updated ifu.
  • Action
    Stryker is advising customers that the current IFU is being updated to reflect the new contraindications. Users are to maintain awareness of the updated contraindication to ensure the device is not used for fragmentation, emulsification, and aspiration of uterine fibroids.

Device

Instructions For Use (IFU) - Sonopet Ultrasonic Products
  • Modèle / numéro de série
    Instructions For Use (IFU) - Sonopet Ultrasonic ProductsMultiple affected productsARTG numbers:174349 (Stryker Australia - Electrosurgical unit, ultrasonic/mechanical vibration)297743 (Stryker Australia Pty Ltd - Ultrasonic surgical system torque wrench, reusable)298249 (Stryker Australia - Electrode handpiece, electrosurgical, ultrasonic/mechanical vibration, foot-controlled)
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

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