Events

Retiro De Equipo (Recall) de AMS AdVance XP Male Sling System - Needle passers

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 American Medical Systems 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
    17127
  • Fecha de inicio del evento
    2014-08-06
  • 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
    As a result of routine periodic product shelf life testing, manufacturer has identified that the sterile barrier of some samples of packaging of the needle passer components supplied with the advance® xp male sling system, may have potentially been breached and therefore do not consistently meet the three (3) year shelf life stated on the product label. further testing confirms that the packaging of the needle passers continues to meet the requirements for the one (1) year shelf life., during implant procedures of the advance® xp male sling system, the two needle passers (left and right sides), are used by the surgeon to assist transobturator passage while the placing and positioning the sling. these tools are disposable and indicated for one-time-use only. there is a potential for an increased risk of patient infection due to breach in the sterile barrier (packaging) of the needle passer components.
  • Acción
    Product to be returned to supplier

Device

AMS AdVance XP Male Sling System - Needle passers

Manufacturer

American Medical Systems Inc
  • Source
    NZMMDSA