Events

Rappel de Sonopet Console (Ultrasonic Surgical Aspirator System)

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-2014-RN-00769-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-07-16
  • 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-2014-RN-00769-1
  • 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
    Stryker has noticed a trend of complaints regarding insufficient irrigation to the tip of the sonopet system. lack of irrigation can potentially lead to excessive heat at the tip. in the case where the irrigation pump fails, saline would not be provided to the tip. as a result the cooling function would be lost and could potentially cause the tip to heat up resulting in tissue burns to the patient.
  • Action
    Stryker has updated the Instructions for Use (IFU) for Sonopet to include the following clarifications: · DO NOT use a rigid non-collapsible irrigation container. Failure to comply may cause the flow of irrigation to be drastically reduced and result in overheating of the handpiece tip and/or tip cover. Only use a collapsible irrigation container. · The irrigation tube must be properly routed through the irrigation pump with the pump cover fully closed and latched. Improper setup of the irrigation tubing may result in an inconsistent or lack of irrigation. · Provide adequate irrigation to the tip to avoid excessive heat that could result in tissue damage due to unintended contact. Additionally, all existing Sonopet consoles will have an instructional irrigation setup label applied to the side of the console. This action has been closed-out on 03/06/2016.

Device

Sonopet Console (Ultrasonic Surgical Aspirator System)
  • Modèle / numéro de série
    Sonopet Console (Ultrasonic Surgical Aspirator System)Catalogue Number: 5450852000All Serial NumbersARTG Number: 174364
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

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