Events

Alerte De Sécurité sur Endo Peanut 5 mm Device

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par Medtronic.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • Date
    2017-05-19
  • Date de publication de l'événement
    2017-05-19
  • Pays de l'événement
    Hong Kong
  • Source de l'événement
    DH
  • URL de la source de l'événement
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20170520a.html
  • Notes / Alertes
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Notes supplémentaires dans les données
    Medical Device Safety Alert
  • Cause
    Medical device safety alert: medtronic endo peanut 5 mm device medical device manufacturer, medtronic, has issued a medical device safety alert concerning its endo peanut 5 mm device. [item code: 173019; lot numbers: m5k04x to m7a01x; expiration: october 2020 through january 2022]. according to the manufacturer, the voluntary recall is being conducted following reports that the cotton tip of the device may disengage due to insufficient adhesive application during the manufacturing process. the use of products with this issue may increase the potential for the tip to disengage resulting in possible extension of operating room time or the need for unintended radiation exposure via x-ray for detection of the foreign body. while four reports indicate that patients required an intraoperative x-ray to locate the disengaged tip, and in one case the tip was not retrieved subsequent to x-ray, no patient injury or impairment has been reported. the manufacturer requests customers to quarantine and return any unused products.. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 19 may 2017.

Device

Endo Peanut 5 mm Device
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Medtronic Endo Peanut 5 mm Device
  • Manufacturer
    Medtronic

Manufacturer

Medtronic
  • 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
    DH