Events

Retiro De Equipo (Recall) de Gyrus ACMI PKS Seal Open Forceps.

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 Gyrus ACMI Corporation.

¿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
    53890
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0633-2010
  • Fecha de inicio del evento
    2009-08-18
  • Fecha de publicación del evento
    2010-01-14
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-03-06
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=86812
  • 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 and coagulation device and accessories. - Product Code GEI
  • Causa
    Gyrus acmi received complaints of a problem with 3103pk, 3104pk, 3105pk, 915000pk, 915005pk, 915010pk - gyrus acmi pks seal open forceps. the metal shim between the jaws may detach during the procedure and fall into the surgical field. the detached shim may be undetected and be left behind in the patient. this circumstance could subsequently cause complications. further use of this product sh.
  • Acción
    An Urgent Medical Device Recall letter, dated 08/15/09 was sent to customers notifying them of the issue. The letter identified affected product, asked that they cease further use, remove affected devices from stockrooms, contact Gyrus ACMI customer service for a return goods authorization and return product to Gyrus ACMI at no charge. A reply form is also asked to be returned to Gyrus ACMI via fax. Questions and requests for a Return Goods Authorization are directed to Gyrus ACMI customer service at 1-888-524-7266.

Device

Gyrus ACMI PKS Seal Open Forceps.
  • Modelo / Serial
    all lots
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US and International distribution. OUS to Include: Australia, Belgium, Bolivia, Bulgaria, Canada, Chile, China, Columbia, Croatia, Czech, Denmark, Ecuador, Estonia, Finland, France, Germany, Greece , Hong Kong, India, Ireland, Israel, Italy, Japan, Korea, Malaysia, Mexico, Netherlands, Panama, Puerto Rico, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, United Kingdom.
  • Descripción del producto
    Gyrus ACMI PKS Seal Open Forceps, model 915010PK, 9-3/4" Angled Jaw. Sterile EO. The device is intended to be used with the G400 electrosurgical generator. Gyrus ACMI, Inc., 136 Turnpike Road, Southborough, MA 01772-2104 USA.
  • Manufacturer
    Gyrus ACMI Corporation

Manufacturer

Gyrus ACMI Corporation
  • Dirección del fabricante
    Gyrus ACMI Corporation, 136 Turnpike Rd, Southborough MA 01772-2118
  • Source
    USFDA