Events

Rappel de Stryker Medtech - IIb - 36273; Ultrasonic surgical system generator

Selon New Zealand Medicines and Medical Devices Safety Authority, ce/cet/cette rappel concerne un dispositif en/au/aux/à New Zealand qui a été fabriqué par Stryker Medtech K.K..

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    22799
  • Date de mise en oeuvre de l'événement
    2018-04-11
  • Pays de l'événement
    New Zealand
  • Source de l'événement
    NZMMDSA
  • URL de la source de l'événement
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Recalling Organisation: Stryker New Zealand Ltd, 515 Mt Wellington Highway, Mt Wellington, AUCKLAND 1060
  • Cause
    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.
  • Action
    Instructions for use to be updated

Device

Stryker Medtech - IIb - 36273; Ultrasonic surgical system generator
  • Modèle / numéro de série
    Model: Sonopet 110V Console with Foot Pedal and Pole, Sonopet 100V Console with Foot Pedal and Pole, Sonopet 230V Console with Foot Pedal and Pole, Affected:
  • Manufacturer
    Stryker Medtech K.K.

Manufacturer

Stryker Medtech K.K.
  • Société-mère du fabricant (2017)
    Stryker
  • Source
    NZMMDSA