Events

Retiro De Equipo (Recall) de DA VINCI SURGICAL SYSTEM (MODEL IS1000)

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por MINOGUE MEDICAL 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
    33058
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2013-08-12
  • 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
    A revised instructions for use (ifu) for reprocessing of da vinci endowrist instruments will be released. these changes have been implemented to ensure customers have clear information related to the use and reprocessing of da vinci instruments and accessories and to assist da vinci customers with compliance to local requirements. the current ifu is still valid. this update improves the process improves the clarity of the instructions themselves and allows for alkaline cleaners and is not being performed for safety issues or the ifu is defective.

Device

DA VINCI SURGICAL SYSTEM (MODEL IS1000)
  • Modelo / Serial
    Model Catalog: IS1200 (Lot serial: S00173); Model Catalog: IS1200 (Lot serial: S00150); Model Catalog: IS1200 (Lot serial: S00305); Model Catalog: IS3000 (Lot serial: >10 serial numbers.); Model Catalog: IS3000 (Lot serial: Contact manufacturer.); Model Catalog: IS1200 (Lot serial: S00421); Model Catalog: IS2000 (Lot serial: SG345); Model Catalog: IS2000 (Lot serial: SG242); Model Catalog: IS2000 (Lot serial: SG268); Model Catalog: IS2000 (Lot serial: SG570); Model Catalog: IS2000 (Lot serial: SG431); Model Catalog: IS2000 (Lot serial: SG359)
  • Descripción del producto
    Da Vinci Surgical System (Model IS1000)
  • Manufacturer
    MINOGUE MEDICAL INC.

Manufacturer

MINOGUE MEDICAL INC.