Events

Alerte De Sécurité sur Offset Cup Impactor Universal

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

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
    2015-01-16
  • Date de publication de l'événement
    2015-01-16
  • 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_20150116.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: brainlab offset cup impactor universal medical device manufacturer, brainlab, has issued a field safety notice concerning brainlab offset cup impactor universal [reference number: 52856/52856a]. the manufacturer identified that when the device is reprocessed according to the instructions in the current brainlab cleaning, disinfection and sterilization guide (revision 4.9 and previous), the device may not be determined as sterile. the required sterility assurance level (sal) of 10-6 is not reliably achieved with the currently specified steam sterilization cycles and associated drying times. if a non-sterile offset cup impactor universal is used during a surgical procedure to implant an acetabular cup, contaminated residues on the product surface could enter the patient’s body, potentially leading to infection and serious injury or even death of the patient. the manufacturer advises users to follow newly validated sterilization cycles to achieve the required sterility assurance level (sal) of 10-6. according to the local supplier, the affected product is distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 16 january 2015.

Device

Offset Cup Impactor Universal
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Brainlab Offset Cup Impactor Universal
  • Manufacturer
    Brainlab

Manufacturer

Brainlab