Events

Rappel de da Vinci Xi EndoWrist Stapler

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Device Technologies 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-2016-RN-01006-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2016-08-09
  • 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-2016-RN-01006-1
  • 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
    There has been an increase in the number of complaints regarding the “stapler firing failed” message for the xi stapler. all cases involving the complaints were completed minimally invasively. one complaint of partial fire resulted in a serious injury when a partial fire across an artery resulted in bleeding (1/12900 xi staple procedures = 0.01%), which was resolved through use of pressure, suture, and a clip.The failure message interrupts the stapler firing prior to completion of the full staple line. when this error occurs, the transection of tissue may be incomplete. in all cases formed staples precede the cut line however; there may be unformed staples at the end of the line. the knife blade could be exposed. while this message can occur with gray, white, blue, or green reloads, the greatest concern is with gray and white reloads, where a partial fire could potentially occur while transecting critical vascular structures such as pulmonary, renal or splenic vessels.
  • Action
    Device Technologies is advising users that In the event of the “Stapler Firing Failed” message, please note the following: 1. While the Stapler remains in the clamped state, it provides compression and tamponades the vasculature. 2. Surgeons should ensure hemostatic and leak control, particularly when around critical vessels with the gray or white reload, before releasing the Stapler from the structure. 3. After unclamping, a blade may be exposed; hence, surgeons should not manipulate tissue with the Stapler after the “Stapler Firing Failed” message occurs. 4. Bedside assistants should take care when removing the fired reload, as sharps hazards, such as potentially exposed knife and unformed staples, may be present. A software correction has been completed as a permanent correction. This action has been closed-out on 03/02/2017.

Device

da Vinci Xi EndoWrist Stapler

Manufacturer

Device Technologies Australia Pty Ltd