Events

Rappel de GastriSail Gastric Positioning 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 Medtronic Australasia 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-2017-RN-01227-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-09-27
  • 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-2017-RN-01227-1
  • 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
    Medtronic is recalling specific production lots of its gastrisail gastric positioning system device. this recall is being conducted following customer reports of oesophageal or gastric perforations during bariatric procedures where the gastrisai gastric positioning system was used. eighteen reports, representing 0.08% of devices, were received regarding this issue; many of these perforations were identified post-operatively. according to complaints, the part of the device causing perforation may be the distal tip during device insertion or when meeting resistance as it is advanced. some complaints also referenced tissue trauma or perforation thought to be caused by inability to fully retract the sail, leading to kinking of the sail and risk to tissue.
  • Action
    Medtronic requests that users quarantine and return any unused products of the items. All unused products from the affected item code and lots should be returned to Medtronic.

Device

GastriSail Gastric Positioning System
  • Modèle / numéro de série
    GastriSail Gastric Positioning SystemItem Code: GPS36All Lot NumbersExpiry date: September 2017 to May 2018ARTG Number: 246455
  • Manufacturer
    Medtronic Australasia Pty Ltd

Manufacturer

Medtronic Australasia Pty Ltd
  • Société-mère du fabricant (2017)
    Medtronic plc
  • Commentaire du fabricant
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    DHTGA