Events

Retiro De Equipo (Recall) de Device Recall monopolar pencil

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 Olsen Medical.

¿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
    80080
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1941-2018
  • Fecha de inicio del evento
    2018-05-11
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=164427
  • 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
    Electrosurgical, cutting & coagulation & accessories - Product Code GEI
  • Causa
    Products may encroach into the sterile pouch seal thereby increasing the risk of the seal being compromised.
  • Acción
    Symmetry initiated their recall via Urgent Medical Device Recall notices on 05/11/2018 sending faxes to accounts, as applicable; and, will also send the Notice via US certified mail, with return receipt requested, and will also send the Notice via e-mail to those customers for which it has a valid e-mail address (as applicable). All customers were asked to quarantine any products that reflect a breach of the seal area or any products that they do not wish to inspect immediately and promptly call (800) 251-3000 for a return material authorization (RMA) number to support the return of the impacted Products. All customers outside of the United States (OUS) will be provided with the Notice via postal mail and through Symmetrys Distributors in each country and requested to quarantine immediately and promptly call Symmetry's Distributors to support the return of any products that have a breach of the seal area or which the customer does not wish to inspect. Appropriate notifications will be sent to Health Authorities in Canada, European Union, and other countries that require notification of this recall.

Device

Device Recall monopolar pencil
  • Modelo / Serial
    all codes
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution
  • Descripción del producto
    Symmetry Olsen Monopolar Pencil: || (a) Button Switchpen, w/ Standard Needle Electrode REF 75505, QTY 50 || (b) Button Switchpen, w/ Standard Blade Electrode, REF 75530, QTY 50 || (c) Rocker Switchpen, w/ Standard Blade Electrode, REF 75610, QTY 50 || (d) Button Switchpen, w/ Extendable Blade Electrode, 10 mm Exposure, REF 75800, QTY 25 || (e) Button Switchpen, w/ Extendable Blade Electrode, 2 mm Exposure, REF 75810, QTY 25 || (f) Button Switchpen, w/ Extendable Needle Electrode, 2 mm Exposure, REF 75820, QTY 25 || (g) Foot Controlled Handle, w / Standard Blade electrode, REF 95012, QTY 100 || Designed to hold active electrodes.
  • Manufacturer
    Olsen Medical

Manufacturer

Olsen Medical
  • Dirección del fabricante
    Olsen Medical, 3230 Commerce Center Pl, Louisville KY 40211-1900
  • Empresa matriz del fabricante (2017)
    Olsen Medical Llc
  • Source
    USFDA