Events

Rappel de Classic Series Reusable Active Cord Designed to be used with Gyrus ACMI FOCUS 640, Bovie and other general purpose monopolar electrosurgical generators

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Olympus Australia Pty Ltd.

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
    RC-2018-RN-00326-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2018-04-18
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00326-1
  • Notes / Alertes
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notes supplémentaires dans les données
  • Cause
    Olympus has been made aware by the manufacturer, gyrus acmi, of an issue with the c650-129a classic series reusable cord whereby the cord may become damaged and potentially trigger sparks during use. in the event that cord is damaged, it may short circuit and pose risk of minor electrical shock/burn to the user or patient. if the shorting cable comes in to contact with flammable material there is a risk of fire in the operating room.Investigation of this issue revealed that due to the configuration and location of the cable, the problem could result from users pulling on the cable as opposed to the connector when unplugging the cable. olympus recommends that cables are unplugged by grasping the plug and not by pulling on the cable. to date, there have been no reports of patient injury or death as a result of this issue.Olympus australia has ceased supply of the c650-129a classic series reusable active cord since november 2013.
  • Action
    Olympus is advising users to inspect inventory for any C650-129A Classic Series Reusable Active Cords, cease use and dispose of them accordingly.

Device

Classic Series Reusable Active Cord Designed to be used with Gyrus ACMI FOCUS 640, Bovie and othe...
  • Modèle / numéro de série
    Classic Series Reusable Active CordDesigned to be used with Gyrus ACMI FOCUS 640, Bovie and other general purpose monopolar electrosurgical generatorsModel Number: C650-129AAll Serial NumbersARTG Number:137430(Olympus Australia - Cable/lead, electrosurgical unit)
  • Manufacturer
    Olympus Australia Pty Ltd

Manufacturer

Olympus Australia Pty Ltd