Events

Retiro De Equipo (Recall) de Device Recall GYRUS ACMI, REF 3740, Everest BiCOAG Bipolar Dissecting Forceps 5mm/45 cm, Sterile EO

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 Medical, Inc.

¿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
    65785
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1983-2013
  • Fecha de inicio del evento
    2013-07-24
  • Fecha de publicación del evento
    2013-08-19
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-06-20
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=120141
  • 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
    On april 29, 2013 olympus surgical technologies america r&d; received results from an accelerated aging study conducted as part of a new market submission. the study found that one of 60 dissector units that underwent 3 year accelerated aging failed the dye penetration test indicating that the seal on sterile packaging was compromised. the dissector products are labeled with a 3 year shelf life.
  • Acción
    Olympus sent a "Medical Device Recall" letter dated July 24, 2013, to all affected customers. The letter identified the problem the product and the action needed to be taken by the customer.. Customers were advised to immediately cease any further use of the product and remove it from inventory and quarantine it until is shipped back to the company. To return the product, call 1-888-524-7266 Olympus customer service representative. Customers were requested to complete and return by fax the enclosed questionnaire to 484-896-7128. If the product was further distributed then they need to identify their customers and notify them at once of the product recall.

Device

Device Recall GYRUS ACMI, REF 3740, Everest BiCOAG Bipolar Dissecting Forceps 5mm/45 cm, Sterile EO
  • Modelo / Serial
    REF 3740  150080AC 258624MC G166568CC 381809KD 408020AE JF480565  NY492562  REF 3740PK 128971JB 226730IC 226742IC 226743IC 431894CE 431895CE G128677JB  REF 94201PK  102290EB 147428AC 167021CC 198596GC 204439HC 204451HC 249022KC 278142BD 320659DD 344712FD 363953ID 373761JD 389095MD 418231BE G386412KD G461037EE JF493195
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) including the states of AL, AZ, CA, FL, GA, IL, IN, KS,KY, MD, MA, MI, MN, MS, MO, NY, NC, OH, PA, SD, TN, TX, VA and WI., and the countries of BRAZIL, CHINA, AUSTRALIA, CHINA, GERMANY and INDIA.
  • Descripción del producto
    GYRUS ACMI, REF 3740, Everest BiCOAG Bipolar Dissecting Forceps 5mm/45 cm, Sterile EO. || GYRUS ACMI, REF 3740PK, or REF 94201PK, PKS LYONS, Dissecting Forceps 5mm/45cm, Sterile EO. || The Dissectors are sterile, single use electrosurgical devices that are indicated for the electrosurgical coagulation, mechanical grasping, and dissection of tissue during the performance of laparoscopic and general surgical procedures.
  • Manufacturer
    Gyrus Medical, Inc

Manufacturer

Gyrus Medical, Inc
  • Dirección del fabricante
    Gyrus Medical, Inc, 6655 Wedgwood Rd N Ste 160, Osseo MN 55311-3613
  • Empresa matriz del fabricante (2017)
    Olympus Corporation
  • Source
    USFDA