Events

Retiro De Equipo (Recall) de UNIDRIVE ENT WITH SCB (MOTOR CONTROL UNIT)

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por KARL STORZ ENDOSCOPY CANADA LTD.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    133820
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2015-05-13
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 recall data from the U.S. and Canada.
  • Notas adicionales en la data
  • Causa
    When a laparoscopic power morcellator is used on a patient with (undiagnosed) cancer there is a possibility that the cancer may be upstaged and therefore shorten the patient's life span. health canada posted a safety information notice to hospitals on may 7 2014 regarding the use of the device and risk of spreading unsuspected uterine sarcoma. health canada requested a labelling change under section 39 of the medical devices on december 8 2014 and posted an updated communication on their website on december 10 2014. karl storz is revising their user manuals in compliance with health canada's recommendations.

Device

UNIDRIVE ENT WITH SCB (MOTOR CONTROL UNIT)
  • Modelo / Serial
    Model Catalog: 20701020-1 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 20711120-1 (Lot serial: ALL SERIAL NUMBERS)
  • Descripción del producto
    ROTOCUT MORCELLATOR
  • Manufacturer
    KARL STORZ ENDOSCOPY CANADA LTD

Manufacturer

KARL STORZ ENDOSCOPY CANADA LTD