Events

Retiro De Equipo (Recall) de DA VINCI SURGICAL SYSTEM DRAPE

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
    80214
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2015-04-20
  • 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
    Tears: through standard product quality testing it was noted that the adhesive labels intended to keep the drape folded were found in some instance unintentionally overlapping multiple folds of the drape. cloudy/waxy appearance: through customer feedback intuitive surgical found that some of the drapes used with the da vinci systems may exhibit a cloudy/waxy appearance.

Device

DA VINCI SURGICAL SYSTEM DRAPE
  • Modelo / Serial
    Model Catalog: 420258-01 (Lot serial: > 10 lot numbers contact Mfg); Model Catalog: 420273-02 (Lot serial: > 10 lot numbers contact Mfg); Model Catalog: 420022-02 (Lot serial: > 10 lot numbers contact Mfg); Model Catalog: 420015-03 (Lot serial: > 10 lot numbers contact Mfg); Model Catalog: 420026-01 (Lot serial: > 10 lot numbers contact Mfg); Model Catalog: 420291-03 (Lot serial: > 10 lot numbers contact Mfg); Model Catalog: 420017-03 (Lot serial: >10 numberscontact mfg); Model Catalog: 400027-04 (Lot serial: >10 numberscontact mfg); Model Catalog: 400016-04 (Lot serial: >10 numberscontact mfg); Model Catalog: 400015-03 (Lot serial: >10 numberscontact mfg); Model Catalog: 420290-03 (Lot serial: >10 numberscontact mfg); Model Catalog: 420279-03 (Lot serial: >10 numberscontact mfg); Model Catalog: 420281-02 (Lot serial: >10 numberscontact mfg); Model Catalog: 420273-02 (Lot serial: >10 numberscontact mfg); Model Catalog: 420258-01 (Lot serial: >10 numberscontact mfg); Model Catalog: 420256-01 (Lot serial: >10
  • Descripción del producto
    Da Vinci Surgical System Drape
  • Manufacturer
    MINOGUE MEDICAL INC.

Manufacturer

MINOGUE MEDICAL INC.