Events

Retiro De Equipo (Recall) de LINA GOLD LOOP

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

¿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
    82881
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2011-09-02
  • 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
    This recall has been initiated because in december of 2009 lina medical issued an update to their "instructions for use" (ifu) to inform users that the loops should not be pre-tested on patients nor be used if de-shaped from their original rhomboid form. doing so can cause the loop to weaken break or cease functioning and can prolong the surgery of the patient.

Device

LINA GOLD LOOP
  • Modelo / Serial
    Model Catalog: EL-200-8 (Lot serial: 00-H557000); Model Catalog: EL-200-4 (Lot serial: 00-H557000); Model Catalog: EL-160-8 (Lot serial: 00-H557000); Model Catalog: EL-200-8 (Lot serial: 00-O932300); Model Catalog: EL-200-4 (Lot serial: 00-O932300); Model Catalog: EL-160-8 (Lot serial: 00-O932300); Model Catalog: EL-200-8 (Lot serial: 00-C908986); Model Catalog: EL-200-4 (Lot serial: 00-C908986); Model Catalog: EL-160-8 (Lot serial: 00-C908986); Model Catalog: EL-200-8 (Lot serial: 00-V131400); Model Catalog: EL-200-4 (Lot serial: 00-V131400); Model Catalog: EL-200-8 (Lot serial: 00-S123960); Model Catalog: EL-200-4 (Lot serial: 00-S123960); Model Catalog: EL-160-8 (Lot serial: 00-S123960); Model Catalog: EL-160-8 (Lot serial: 00-V131400); Model Catalog: EL-200-8 (Lot serial: 00-B142800); Model Catalog: EL-200-4 (Lot serial: 00-B142800); Model Catalog: EL-160-8 (Lot serial: 00-B142800); Model Catalog: EL-200-8 (Lot serial: 00-C167200); Model Catalog: EL-200-4 (Lot serial: 00-C167200); Model Catalog: EL-160-8
  • Descripción del producto
    LINA LOOP ENDOSCOPIC MONOPOLAR LOOP
  • Manufacturer
    SUPERIOR MEDICAL LIMITED

Manufacturer

SUPERIOR MEDICAL LIMITED