Events

Rappel de Instrument Star Unit ML (Calibration with ICM4) (part of Brainlab Spine & Trauma Navigation 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 Brainlab 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-01273-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2013-11-29
  • 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-01273-1
  • 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 manufacturer, brainlab ag has determined that pins of the instrument star unit ml (calibration with icm4) with specific serial numbers might have been made using an incorrect material that is not suitable for necessary disinfection and sterilisation of the product. consequently, the biocompatibility of these specific products cannot be ensured. pins made of this incorrect material will not withstand the necessary reprocessing procedures described in the brainlab cleaning, disinfection and sterilisation guide. the prescribed reprocessing procedures will cause visible corrosion of pins made of this incorrect material. one or multiple pins of each product might be affected. if this corrosion occurs and is not detected by the user, and the device is used during surgery, corroded particles of the pin could, directly or indirectly, enter the patient’s body, potentially leading to infection and serious injury of the patient.
  • Action
    Customers are asked to identify the affected Instrument Star Units ML and remove them from clinical use. Brainlab Australia will arrange for affected stock to be recovered and replacement stock or a credit note to be issued.

Device

Instrument Star Unit ML (Calibration with ICM4) (part of Brainlab Spine & Trauma Navigation System)
  • Modèle / numéro de série
    Instrument Star Unit ML (Calibration with ICM4) (part of Brainlab Spine & Trauma Navigation System)Brainlab Article Number: 55830-25ASerial Numbers: 1205112016 and 1205112026ARTG Number: 96517
  • Manufacturer
    Brainlab Australia Pty Ltd

Manufacturer

Brainlab Australia Pty Ltd