Events

Rappel de Covidien EEA Haemorrhoid and Prolapse Stapler Set with DST Series Technology - 3.5mm staple and 4.8mm staple devices

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-2018-RN-00330-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2018-04-20
  • 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-00330-1
  • 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 has identified the potential for improper welding of the yellow staple guide to the instrument. use of a device with an improperly welded staple guide may result in improper staple formation potentially leading to bleeding and/or an anastomotic leak. this issue was identified during in-process quality testing at the manufacturing facility. to date, there have been no reports of serious injury related to this issue.
  • Action
    Medtronic is advising customers to quarantine and discontinue use of the affected product immediately. Upon receipt of the Response Form provided with the Customer Letter, Medtronic will provide users with a ZRE# to return product and issue credit.

Device

Covidien EEA Haemorrhoid and Prolapse Stapler Set with DST Series Technology - 3.5mm staple and 4...
  • Modèle / numéro de série
    Covidien EEA Haemorrhoid and Prolapse Stapler Set with DST Series Technology - 3.5mm staple and 4.8mm staple devicesProduct Codes: HEM3335 and HEM3348Lot Numbers: N7K0692MX, N7L0594MX, N7J1145MX, N7M0837MX, N7M0837MX ARTG Number: 178674(Medtronic Australasia - Applier, surgical staple, cutting)
  • 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