Events

Retiro De Equipo (Recall) de Device Recall AMS GreenLight PV Surgical Laser System

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 AMS Innovative Center - San Jose.

¿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
    56058
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1229-2011
  • Fecha de inicio del evento
    2010-02-08
  • Fecha de publicación del evento
    2011-02-14
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-02-14
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=92557
  • 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
    A failure mode whereby the fiber attachment to the greenlight pv laser system could inadvertently be broken. if fiber were to bend sharply at point of fiber connection, it may break and cause a burn.
  • Acción
    AMS Innovative Center - San Jose issued Important Product Update Information letters via express mail on February 8, 2010, and September 15, 2010 to all its direct consignees. The letters identified the product, the problem, and the action to be taken by the customer. Customers were instructed to attach the Fiber Guard to their GreenLight PV Laser System, and to complete the Response Form in the enclosed, self-addressed, postage paid envelope to AMS. For any questions regarding this recall call the Customer Care Department at 1-800-356-7600 or send an e-mail to CustomerCare@ammd.com.

Device

Device Recall AMS GreenLight PV Surgical Laser System
  • Modelo / Serial
    All units of the model.
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution including US
  • Descripción del producto
    AMS brand GreenLight PV Laser System, Model-P/N: 0010-9230; || Product is manufactured and distributed by AMS Solutions, || San Jose, CA || The GreenLight Surgical Laser System and accessories are intended for use in endoscopic (cystscopic) KTP 532 nm laser resection of the prostate for the treatment of benign prostatic hyperplasia (BPH). The entire laser unit and controls are contained in a single console that is connected to external electricity and water sources. Fibers are sterile, single-use, disposable fiber optic delivery systems, designed to deliver 532nm laser energy, the fiber is connected to the laser console and used to cut, coagulate and vaporize prostate tissue.
  • Manufacturer
    AMS Innovative Center - San Jose

Manufacturer

AMS Innovative Center - San Jose
  • Dirección del fabricante
    AMS Innovative Center - San Jose, 3070 Orchard Dr, San Jose CA 95134-2011
  • Source
    USFDA