Events

Retiro De Equipo (Recall) de Stryker Medtech - IIb - 44750; Soft-tissue ultrasonic surgical system handpiece, foot controlled reusable

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 Stryker Medtech K.K..

¿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
    22799
  • Fecha de inicio del evento
    2018-04-11
  • 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: Stryker New Zealand Ltd, 515 Mt Wellington Highway, Mt Wellington, AUCKLAND 1060
  • Causa
    Additional information is being added to the instructions for use (ifu) for sonopet® ultrasonic products. ultrasonic surgical aspirator devices use an oscillating tip to cause tissue fragmentation through the delivery of ultrasound energy to target tissue. the potential for tissue dissemination is mitigated, but not completely eliminated, by the use of suction/aspiration. although fda is not aware of reports of dissemination or upstaging of occult uterine malignancies related to ultrasonic surgical aspirators at this time, the agency is recommending that all device manufacturers add a contraindication against use for the removal of uterine fibroids.
  • Acción
    Instructions for use to be updated

Device

Stryker Medtech - IIb - 44750; Soft-tissue ultrasonic surgical system handpiece, foot controlled ...
  • Modelo / Serial
    Model: , Affected: Small Long Angled Handpiece, Hyper Small Angled Handpiece
  • Manufacturer
    Stryker Medtech K.K.

Manufacturer

Stryker Medtech K.K.
  • Empresa matriz del fabricante (2017)
    Stryker
  • Source
    NZMMDSA