Events

Rappel de Intuitive Surgical laparoscopic instruments activated by da Vinci SiTM Single Site Grip Release mechanism

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 Intuitive Surgical Inc.

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
    19422
  • Date de mise en oeuvre de l'événement
    2015-11-23
  • 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: Device Technologies New Zealand, 47 Arrenway Drive, Albany, AUCKLAND 0632
  • Cause
    Under rare circumstances, grip actuated instruments may become fixed in a closed position. this potential failure has been attributed to excessive force exerted on the instrument during insertion into a curved cannula, which may result in:, 1. a break in the roll gear and/or instrument shaft, 2. damage to the push/pull mechanism that controls grip opening and closing.
  • Action
    Instructions for use to be updated

Device

Intuitive Surgical laparoscopic instruments activated by da Vinci SiTM Single Site Grip Release m...
  • Modèle / numéro de série
    Model: 428050-12, 428050-13, 428050-14, 428053-12, 428053-15, 428055-12, 428055-13, 428056-12, 428056-13, 428058-12, 428058-13, 428059-12, 428059-13, 428080-04, 428080-05, 428088-12, 428088-13, 428093-12, 428093-13, Affected: All lots
  • Manufacturer
    Intuitive Surgical Inc

Manufacturer

Intuitive Surgical Inc