Events

Retiro De Equipo (Recall) de da Vinci Si EndoWrist One Vessel Sealer and da Vinci Xi EndoWrist Vessel Sealer da Vinci Si EndoWrist One Vessel Sealer

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Device Technologies Australia Pty Ltd.

¿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
    RC-2015-RN-00222-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-03-27
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00222-1
  • Notas / Alertas
    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.
  • Notas adicionales en la data
  • Causa
    Intuitive surgical has identified the potential for a certain, small portion of vessel sealers to exhibit interference in the proximal end (near the joint) of the instrument grips. this interference is due to manufacturing variability in some jaws. the interference can lead to contact between the instrument electrodes at the back of the jaws and subsequent shorting of the electrosurgical energy. the shorting behaviour can lead to extended activation times and insufficient energy delivery to thin, vascular tissue bundles, leading to bleeding if transected. this issue has been identified on a small population of vessel sealers only when used on thin, vascular tissue. there has been no impact identified to sealing performance on larger vessels or tissue bundles.
  • Acción
    Device Technologies Australia (DTA) is informing the customers of the potential for insufficient energy delivery on a small population of Vessel Sealers only when used on thin, vascular tissue and providing instructions on alternative methods of sealing and transection. In caseWhere the customer does not wish to use affected Vessel Sealer instruments, DTA is offering a full credit refund for affected stock in its original packaging. This action has been closed-out on 08/08/2016.

Device

da Vinci Si EndoWrist One Vessel Sealer and da Vinci Xi EndoWrist Vessel Sealer da Vinci Si EndoW...
  • Modelo / Serial
    da Vinci Si EndoWrist One Vessel Sealer and da Vinci Xi EndoWrist Vessel Sealer da Vinci Si EndoWrist One Vessel Sealer Product Code: 410322-05; Order code INS-410322Multiple Lot Numbersda Vinci Xi EndoWrist Vessel Sealer Product Code: 480322-04; Order Code INS-180322Multiple Lot NumbersARTG Number: 132453
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd