Events

Alerta De Seguridad para Model 0606-0300-50 Laserscope Pulsar / Paragon Carbon Dioxide Lasers

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Laserscope.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • ID del evento
    176
  • Fecha
    2000-09-20
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notas / Alertas
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 data from the U.S. and Brazil.
  • Notas adicionales en la data
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Causa
    An ecri member hospital reports that when using the model 0606-0300-50 laserscope pulsar / carbon dioxide (co2) lasers for throat surgery, the otolaryngologist complained that the helio / neon laser beam (hene) , which indicates the area where the laser will reach the tissue, was not clear enough to be used.
  • Acción
    ECRI makes the following recommendations: (1) Examine the target beam conditions of any Pulsar / Paragon CO2 laser in your hospital during inspection and preventive maintenance to detect any wear of the attenuator over time. Make sure that the aiming beam is immediately visible, especially when used with external light sources. (2) If the beam does not appear to be clear enough, make sure it is set to maximum intensity. If this does not solve, exclude other problems, such as those involving the micro manipulator or wear of the HeNe tube or the power source. (3) If the attenuator is the problem, consider removing the HeNe attenuator assembly (or ask the Laserscope manufacturer to do so). By doing so, you will be avoiding the effort and expense of having to incorporate a Laserscope crosshair upgrade kit, however this will also eliminate the ability to adjust the beam brightness (4) If this does not work , install the Laserscope NeHe upgrade kit. Contact your local representative or directly with Laserscope at 1 (408) 943-0636 in the United States to discuss this option. It may be covered by the original service agreement (warranty) or warranty. Otherwise, Laserscope has stated that the total cost of the service is $ 3,900 (including labor and travel). For more information, contact your local representative or directly with Laserscope at 1 (408) 943-0636 in the United States at fax 1 (408) 428-0512, or visit the Laserscope Web site at http: / /www.laserscope.com

Device

Model 0606-0300-50 Laserscope Pulsar / Paragon Carbon Dioxide Lasers

Manufacturer

Laserscope
  • Source
    ANVSANVISA