Events

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

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Laserscope.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    176
  • Date
    2000-09-20
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    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.
  • Extra notes in the data
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Reason
    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.
  • Action
    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