Events

Retiro De Equipo (Recall) de INTUBATION FIBERSCOPE

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por KARL STORZ SE & CO. KG.

¿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
    98924
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2013-11-07
  • 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
    It has been determined that these endoscopes incorporate a lumen material that is only approved for use as an external surface material and not included in the sterrad nx and 100nx labeling claims for use in flexible endoscope lumens. this could result in lower than expected levels of hydrogen peroxide within the lumen during the exposure phase of the sterilization cycle and compromise sterilization efficacy.

Device

INTUBATION FIBERSCOPE
  • Modelo / Serial
    Model Catalog: 11301AA1 (Lot serial: All numbers affected.); Model Catalog: 11004BC1 (Lot serial: All numbers affected.); Model Catalog: 11301BN1 (Lot serial: All numbers affected.); Model Catalog: 11302BD1 (Lot serial: All numbers affected.); Model Catalog: 11302BD2 (Lot serial: All numbers affected.); Model Catalog: 11302BDD2 (Lot serial: All numbers affected.); Model Catalog: 11009BC1 (Lot serial: All numbers affected.); Model Catalog: 11340BC1 (Lot serial: All numbers affected.); Model Catalog: 11304BC1 (Lot serial: All numbers affected.); Model Catalog: 11302BDD1 (Lot serial: All numbers affected.); Model Catalog: 11301BND1 (Lot serial: All numbers affected.); Model Catalog: 11001BN1 (Lot serial: All numbers affected.); Model Catalog: 11002BD1 (Lot serial: All numbers affected.)
  • Descripción del producto
    B. Flexible Intubation Fiberscopes with Suction Port
  • Manufacturer
    KARL STORZ SE & CO. KG

Manufacturer

KARL STORZ SE & CO. KG