Alerta De Seguridad para Hercules 360 Universal Stabilizing Arm

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por Terumo Cardiovascular Systems.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • Fecha
    2014-09-16
  • Fecha de publicación del evento
    2014-09-16
  • País del evento
  • Fuente del evento
    DH
  • URL de la fuente del evento
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Medical Device Safety Alert
  • Causa
    Medical device safety alert: terumo cvs hercules 360 universal stabilizing arm medical device manufacturer, terumo cardiovascular systems (cvs) corporation has issued a field safety notice concerning its hercules 360 universal stabilizing arm, top mount, 360-degree rotation, reusable stainless steel, with the following details: catalogue number: 001-401-160 serial number: 70194 through 70504; dates of distribution: 2 april 2012 through 23 july 2014 the manufacturer is recalling certain lots of hercules 360 universal stabilizing arms because the two pins that hold the sleeve attached to the distal end of the device may come loose, causing the pins and sleeve to separate from the device. while the arm can still function without the pins and sleeve in place, there is potential for the loose components to fall into the surgical site. the manufacturer has received nine complaints of the pins and sleeve separating from the device either prior to or during a procedure since may 2013. there are no reported injuries as a result of this issue. the pin and sleeve components are made of stainless steel and have a relatively smooth surface with no sharp or pointed features. if a component falls into a patient’s body cavity, it is unlikely to cause patient injury. the event could, however, lead to delay in procedure as the surgeon retrieves the component. other risks involve not having a back-up device which could necessitate converting from an off-pump procedure to an on-pump procedure using a heart-lung machine. this would create a delay in procedure and eliminate the potential benefits associated with a beating heart procedure. the manufacturer has determined that this issue is a result of a design change in the manufacturing process that occurred prior to the manufacturer acquiring the product line and the manufacturer is taking corrective action. the manufacturer advises users to stop using hercules 360 universal stabilizing arms from the affected serial number range and return all affected product to the manufacturer. furthermore, the manufacturer will provide users with a hercules 3 universal stabilizing arm for interim use until a replacement hercules 360 universal stabilizing arm is available (expected in october 2014). according to the local supplier, the affected products were not distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 16 sep 2014.

Device

  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Terumo CVS Hercules 360 Universal Stabilizing Arm
  • Manufacturer

Manufacturer