Events

Alerte De Sécurité sur Cosman Medical Nitinol RF (TCN) Reusable Electrodes

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

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
    2017-07-07
  • Date de publication de l'événement
    2017-07-07
  • 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_20170707b.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: boston scientific cosman medical nitinol rf (tcn) reusable electrodes medical device manufacturer, boston scientific, has issued a medical device safety alert concerning its cosman medical nitinol rf (tcn) reusable electrodes. the tcn electrodes were manufactured by cosman medical, a wholly-owned subsidiary of boston scientific, and affected units are labeled as cosman. the affected products are tcn-5, tcn-15-3m, tcnk-5-r, tcnk-15-c, tcn-5-3m, tcn-20, tcnk-10, tcnk-15-r, tcn-10, tcn-20-3m, tcnk-10-c, tcnk-20, tcn-10-3m, tcnk-5, tcnk-10-r, tcnk-20-c, tcn-15, tcnk-5-c, tcnk-15 and tcnk-20-r. according to the manufacturer, there have been complaints that after multiple reprocessing cycles, the epoxy resin which holds the tcn electrode in the hub can exhibit signs of damage. in some cases, this damage may result in the inability to fully remove blood and/or tissue residuals prior to cleaning and re-sterilizing the device. the failure to completely remove any blood and/or tissue from the tcn electrodes prior to re-sterilization creates a potential risk of infection and spread of blood borne pathogens to patients. the manufacturer has not received any reports of patient injury related to this issue. cosman stainless steel (csk) and disposable (tcd/cu/cur) electrodes are not affected by this action. the manufacturer advises users to take the following actions: if users have any of these affected electrodes within their inventory that have not been used, segregate the product immediately. unused/un-opened tcn electrodes should be identified as single use only (for one patient). these devices are supplied as non-sterile which require cleaning and sterilization prior to use. these tcn electrodes may be used once the cleaning and sterilization steps are completed. after single use, the used tcn electrode should be disposed of in accordance with their institution’s infectious material/biohazard waste control procedures. used tcn electrodes should be disposed immediately in accordance with their institution’s infectious material/biohazard waste control procedures. users should immediately discontinue use of devices that have already been used. 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 7 july 2017.

Device

Cosman Medical Nitinol RF (TCN) Reusable Electrodes
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Boston Scientific Cosman Medical Nitinol RF (TCN) Reusable Electrodes
  • Manufacturer
    Boston Scientific

Manufacturer

Boston Scientific
  • Société-mère du fabricant (2017)
    Boston Scientific
  • Commentaire du fabricant
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    DH