Events

Retiro De Equipo (Recall) de Device Recall NeuroBlate System SideFire Select 2.2 mm Directional Laser Probe

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Monteris Medical Corp.

¿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
    73849
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-1614-2016
  • Fecha de inicio del evento
    2016-03-25
  • Fecha de publicación del evento
    2016-05-16
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-03-10
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=145141
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Powered laser surgical instrument - Product Code GEX
  • Causa
    Monteris received a report that the sapphire lens on a 2.2sf probe fractured during a litt procedure, with resulting introduction of c02 into the patient's brain.
  • Acción
    Monteris Medical Corporation field personnel visited each consignee starting March 25, 2016 and April 1, 2016. The devices were physically removed from each site. Customers from whom the devices were removed will either receive a credit or receive replacements of other models of laser delivery probes.

Device

Device Recall NeuroBlate System SideFire Select 2.2 mm Directional Laser Probe
  • Modelo / Serial
    All unexpired lots of these models are being removed from the market.
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution in the states of KS, MO, NC, OH, and VA.
  • Descripción del producto
    NeuroBlate System SideFire Select 2.2 mm Directional Laser Probe, Sterile EO. Model #s SFS000-01,SFS002-01, SFS122-01, SFS222-01, SFS322-01, SFS422-01, and SFS522-01. || NeuroBlate System SideFire Select Directional Laser Probes are part of the NeuroBlate System. The Monteris Medical NeuroBlate System is indicated for use to ablate, necrotize, or coagulate soft tissue through interstitial irradiation or thermal therapy in medicine and surgery in the discipline of neurosurgery with 1064 nm lasers. The Monteris Medical NeuroBlate System is intended for planning and monitoring thermal therapies under MRI visualization. It also provides real-time thermographic analysis of selected MRI images. The laser delivery probes direct the laser energy to the proper treatment location.
  • Manufacturer
    Monteris Medical Corp

Manufacturer

Monteris Medical Corp
  • Dirección del fabricante
    Monteris Medical Corp, 16305 36th Ave N Suite 200, Plymouth MN 55446-2884
  • Empresa matriz del fabricante (2017)
    Monteris Medical Corp
  • Source
    USFDA