Events

Alerte De Sécurité sur Sarns™ Sternal Saw I System

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

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
    2011-11-23
  • 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_20111123a.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
    Field safety notice: terumo cvs sarns™ sternal saw i system medical device manufacturer, terumo cardiovascular system (terumo cvs), has issued an field safety notice concerning sarns™ sternal saw i system. terumo cvs has received one report of minute metal shavings leaking from the sarns™ sternal saw i system at the point where the saw blade is inserted into the saw hand piece. if metal shavings fall into the surgical site, the immediate and long range effect on the patient would be determined by the volume of metal and whether or not any other residue form inside the saw also leaked into the wound. the body would recognize the presence of the material as a foreign surface and would initiate an inflammatory response, which would range in severity from a mild localized response to a major systemic inflammatory response. either of these could lead to an increase in morbidity to the cardiac surgery patient. no patient injury and no impact to the surgical procedure were reported with this incident. terumo cvs is removing all sternal saw i system from the field. according to the manufacturer, hong kong is not affected. if you are in possession of the affected products, please contact your supplier for necessary actions. .

Device

Sarns™ Sternal Saw I System
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Terumo CVS Sarns™ Sternal Saw I System
  • Manufacturer
    Terumo Cardiovascular System

Manufacturer

Terumo Cardiovascular System