Events

Retiro De Equipo (Recall) de J-PLASMA HANDPIECE BLADE TIP PISTOL GRIP

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por BOVIE MEDICAL CORPORATION.

¿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
    30411
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2018-02-09
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notas adicionales en la data
  • Causa
    Bovie medical has become aware of an issue caused by incomplete insertion of the j-plasma handpiece cable plug into the generator receptacle. when the j-plasma handpiece with generator is used during surgical procedures without the cable plug being completely inserted into thgenerator the green indicator light to the left of the receptacle will illuminate event with an incomplete cable plug insertion. there have been no patient injuries reported as a result of this issue.

Device

J-PLASMA HANDPIECE BLADE TIP PISTOL GRIP
  • Modelo / Serial
    Model Catalog: BVX-330B (Lot serial: ALL); Model Catalog: BVX-270B (Lot serial: ALL); Model Catalog: BVX-330BR (Lot serial: ALL); Model Catalog: BVX-150BPP (Lot serial: ALL); Model Catalog: BVX-150B (Lot serial: ALL)
  • Descripción del producto
    J-PLASMA HANDPIECE BLADE TIP PISTOL GRIP
  • Manufacturer
    BOVIE MEDICAL CORPORATION

Manufacturer

BOVIE MEDICAL CORPORATION