Events

Rappel de Intuitive Surgical Endowrist Instruments Hot Shears- Monopolar Curved Scissors

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
    14736
  • Date de mise en oeuvre de l'événement
    2013-05-30
  • 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
    Manufacturer has identified a potential for some units of the monopolar curved scissors (mcs) to develop very small cracks.("micro-cracks") near the distal (scissor) end. this may create a pathway for electrosurgical energy to leak to tissue and potentially cause thermal injury. there is alos a risk that procedure time may be increased if the device needs to be replaced during surgery.
  • Action
    Product to be returned to supplier

Device

Intuitive Surgical Endowrist Instruments Hot Shears- Monopolar Curved Scissors
  • Modèle / numéro de série
    Model: INS-420179 and INS-400179, Affected: -09 and -10
  • Manufacturer
    Intuitive Surgical Inc

Manufacturer

Intuitive Surgical Inc