Events

Rappel de Percuvance Percutaneous Surgical System

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Teleflex Medical 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-2017-RN-01400-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2017-11-13
  • 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-2017-RN-01400-1
  • 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
    Teleflex has identified that the percuvance percutanous surgical system jaws of the tool tip may break, causing a fragment of the tool tip to fall off during use. if breakage occurs during a procedure, additional operating time or enlargement of the incision may be required to retrieve the fragment from the patient. if the fragment cannot be retrieved easily, additional complications could occur. teleflex has not received any reports of patient injuries or deaths relating to the recalled products.
  • Action
    Teleflex is advising users to quarantine any remaining units of the affected stock for credit.

Device

Percuvance Percutaneous Surgical System
  • Modèle / numéro de série
    Percuvance Percutaneous Surgical SystemProduct Code: PCVJG5, PCVMD5, PCVHCA5, PVCGG5, PCVSC5Multiple lot Numbers affectedARTG number 126369 (Teleflex Medical Australia Pty Ltd - Applier, surgical, clip, haemostatic, single use)
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Manufacturer
    Teleflex Medical Australia Pty Ltd

Manufacturer

Teleflex Medical Australia Pty Ltd