Events

Rappel de Endowrist Instruments and Accessories for the da Vinci Surgical Systems (Used in endoscopic procedures)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Device Technologies 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-2013-RN-00890-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2013-08-22
  • 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-2013-RN-00890-1
  • 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
    Device technologies australia are implementing a revised reprocessing instructions for endowrist instruments and accessories.The changes include:- to allow the use of mildly alkaline enzymatic cleaners, instead of only ph-neutral enzymatic cleaners.- to clarify soaking prior to active scrubbing and rinsing in order to soften soil and make pre-cleaning easier.- to augment scrubbing by spraying water through the isi-supplier luer nozzle at 2 bar pressure onto the tip of the instrument.- to add magnification to the visual inspection of instruments to make it easier to ensure that instruments are free of visible soil prior to automated reprocessing.
  • Action
    Device Technologies Australia is providing on site training for the revised instructions, review updated content and provide a Cleaning and Sanitation kit (including the revised instructions) for all users.

Device

Endowrist Instruments and Accessories for the da Vinci Surgical Systems (Used in endoscopic proce...
  • Modèle / numéro de série
    Endowrist Instruments and Accessories for the da Vinci Surgical Systems (Used in endoscopic procedures)Part Numbers of Affected Reprocessing Instructions: 550874-02 and 550882-05ARTG Number: 132451
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd