Events

Rappel de Matrix Surgical Laparoscopic Spatula with Cable (Active endotherapy device)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Matrix Surgical 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-2014-RN-00020-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-01-13
  • 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-2014-RN-00020-1
  • 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
    This is a follow up to an earlier recall (tga reference: rc-2012-rn-00637-3) where the insulation of a diathermy spatula appeared to have melted during use and that the patient sustained secondary site damage to their fallopian tube. the manufacturer has determined that the safest maximum operating level for the diathermy spatulas is 30 watts.
  • Action
    Matrix Surgical is advising users to quarantine affected stock for return to Matrix Surgical for replacement or credit note. Updated Instructions for Use (IFU) will be provided to all users along with the newly supplied devices. This action has been closed-out on 11/02/2016.

Device

Matrix Surgical Laparoscopic Spatula with Cable (Active endotherapy device)
  • Modèle / numéro de série
    Matrix Surgical Laparoscopic Spatula with Cable (Active endotherapy device)Product Code: UFPS-133057Lot Numbers: 817101080, 8081106264Product Code: UFPS-133058Lot Numbers: 8191203108, 8191206116, 8191208096, 8191211137, 8191305131, 8191309178Product Code: UFPS-145058Lot Numbers: 8301012171, 4871304081, 830100357ARTG Number: 169175
  • Manufacturer
    Matrix Surgical Pty Ltd

Manufacturer

Matrix Surgical Pty Ltd