Events

Retiro De Equipo (Recall) de Cook Inc Transluminal Biliary Biopsy Forceps Set

Según New Zealand Medicines and Medical Devices Safety Authority, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en New Zealand que fue producido por Cook Incorporated.

¿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
    19954
  • Fecha de inicio del evento
    2016-04-27
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: Obex Medical Ltd, 303 Manukau Road, Epsom, AUCKLAND
  • Causa
    Manufacturer is initiating a recall of listed products as they have identified an increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/ or separation., preliminary investigation into this matter has identified that environmental conditions such as storage temperature, humidity and the use of vapourised hydrogen peroxide for whole-room decontamination within healthcare facilities, may be contributing to this occurrence., potential adverse events that may occur as a result if catheter polymer degradation coudl include loss of device function, separation of a device segment leading to medical intervention, or complications resulting from a separated segment. (eg; device fragments in the vascular system, genitourinary system or other soft tissues).
  • Acción
    Product to be returned to supplier

Device

Cook Inc Transluminal Biliary Biopsy Forceps Set

Manufacturer

Cook Incorporated