Events

Retiro De Equipo (Recall) de Percuvance Percutaneous Surgical System

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Teleflex Medical 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-2017-RN-01400-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2017-11-13
  • 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-2017-RN-01400-1
  • 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
    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.
  • Acción
    Teleflex is advising users to quarantine any remaining units of the affected stock for credit.

Device

Percuvance Percutaneous Surgical System
  • Modelo / Serial
    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)
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Manufacturer
    Teleflex Medical Australia Pty Ltd

Manufacturer

Teleflex Medical Australia Pty Ltd