Events

Retiro De Equipo (Recall) de CONICAL TIP SPIKE

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

¿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
    28492
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2010-02-09
  • 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
    The manufacturer has received one complaint that the trocar tip had fallen off during a surgical procedure. as a consequence the tip needed to be removed in an additional surgical procedure. the trocar tip was detached from the trocar shaft due to a fracture in the weld seam between the tip and shaft.

Device

CONICAL TIP SPIKE
  • Modelo / Serial
    Model Catalog: A5949 (Lot serial: 084W); Model Catalog: A5821 (Lot serial: 075W); Model Catalog: A5949 (Lot serial: 081W); Model Catalog: A5949 (Lot serial: 07YW); Model Catalog: A5949 (Lot serial: 07XW); Model Catalog: A5949 (Lot serial: 078W); Model Catalog: A5949 (Lot serial: 077W); Model Catalog: A5949 (Lot serial: 076W); Model Catalog: A5949 (Lot serial: 075W); Model Catalog: A5948 (Lot serial: 081W); Model Catalog: WA58341L (Lot serial: 081W); Model Catalog: A5821 (Lot serial: 081W); Model Catalog: A5948 (Lot serial: 07YW); Model Catalog: WA58341L (Lot serial: 07YW); Model Catalog: A5821 (Lot serial: 07YW); Model Catalog: A5948 (Lot serial: 07XW); Model Catalog: WA58341L (Lot serial: 07XW); Model Catalog: A5821 (Lot serial: 07XW); Model Catalog: A5948 (Lot serial: 078W); Model Catalog: WA58341L (Lot serial: 078W); Model Catalog: A5821 (Lot serial: 078W); Model Catalog: A5948 (Lot serial: 077W); Model Catalog: WA58341L (Lot serial: 077W); Model Catalog: A5821 (Lot serial: 077W); Model Catalog: A5948 (Lo
  • Descripción del producto
    OLYMPUS TROCAR SPIKES (CONICAL TIP)
  • Manufacturer
    OLYMPUS CANADA INC.

Manufacturer

OLYMPUS CANADA INC.
  • Dirección del fabricante
    RICHMOND HILL
  • Empresa matriz del fabricante (2017)
    Olympus Corporation
  • Source
    HC