Events

Alerta De Seguridad para Continuous-Flow Outer Sheath for Resectoscope

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

¿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
    2015-10-30
  • Fecha de publicación del evento
    2015-10-30
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20151030a.html
  • 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: rudolf medical gmbh continuous-flow outer sheath for resectoscope medical device manufacturer, rudolf medical gmbh, has issued a medical device safety alert concerning its continuous-flow outer sheath for resectoscope [item number: rc260-111, rc220-111]. a customer complaint brought to the manufacturer’s attention that during surgery, irrigation was not possible because the irrigation connections on the outer and inner shaft are not in the corresponding place. further investigation showed that this issue is caused by a general mix-up of the outer shaft geometry. this represents a potential safety risk which could lead to the lengthening or rescheduling of the surgery. the manufacturer advises affected users to quarantine the concerned items in stock. according to the manufacturer, 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 30 october 2015.

Device

Continuous-Flow Outer Sheath for Resectoscope
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Rudolf Medical GmbH Continuous-Flow Outer Sheath for Resectoscope
  • Manufacturer
    Rudolf Medical GmbH

Manufacturer

Rudolf Medical GmbH