Events

Retiro De Equipo (Recall) de Retractor for Sciatic Nerve; and Retractor for Sciatic Nerve, long

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes.

¿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-00938-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-09-18
  • 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-00938-1
  • 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
    Johnson & johnson medical pty. ltd. (jjm) is issuing a medical device recall of certain lots of the depuy synthes sciatic nerve retractors, which are found in the 3.5mm low profile pelvic system. please note that there is no replacement for these products available at this time. micropores may form on the hollow handle of the sciatic nerve retractor during the manufacturing process that are large enough to allow fluids to enter and exit the hollow handle.Even with diligent reprocessing/sterilization of the retractor, subsequent patient(s) may be at risk for infection and adverse tissue reaction due to retained fluids leaking out during use. in the event that the liquid and/or discoloration is not identified preoperatively and enters the operative theatre, there is the potential for surgical delay while a replacement or alternate retractor is requesteda surgical delay may also occur.
  • Acción
    Customers are asked to inspect stock on hand and to quarantine affected units prior to return to JJM for a replacement or an account credit. This action has been closed-out on 05/09/2016.

Device

Retractor for Sciatic Nerve; and Retractor for Sciatic Nerve, long

Manufacturer

Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes