Events

Retiro De Equipo (Recall) de THUNDERBEAT

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 Olympus America 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
    66407
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0432-2014
  • Fecha de publicación del evento
    2013-12-05
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-02-02
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122340
  • 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
    Complaints of damage to various models of thunderbeat hand instruments during surgical procedures, including cracking, breaking, or deformation of the components of the probe tip or jaw.
  • Acción
    Olympus sent an Urgent Medical Device Field Correction Action letter dated September 27, 2013, to all affected customers. The letter identified the product the problem and the actions needed to be taken by the customer. Please make the attached Procedural Tips and Techniques instructions available to all users of the THUNDERBEAT hand instruments. Please also maintain a copy with the Instruction Manual(s) fot"the device. OCA requires that you indicate on the enclosed questionnaire your acknowledgement of receipt of this corrective action and the contact information for your facility. This additional user instruction is also being added to the Instruction Manual(s) for the THUNDERBEAT hand instruments. If you would like a copy of the updated Instruction Manual(s), please contact OAI Customer Service at 1-800-848-9024. For further questions please call (484) 896-5688.

Device

THUNDERBEAT
  • Modelo / Serial
    All sold units
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) including Puerto Rico and Internationally to Canada.
  • Descripción del producto
    TB-0545PC: THUNDERBEAT 5 mm , 45 em, Pistol Grip TB-0535PC: THUNDERBEAT 5 mm, 35 em, Pi stol Grip TB-0545IC: THUNDERBEAT 5 mm, 45 em, In line Grip TB-0535IC: THUNDERBEAT 5 mm, 35 em, Inline Grip TB-0520IC: THUNDERBEAT 5 mm, 20 em, In line Grip TB-051 OIC: THUNDERBEAT 5 mm, I 0 em, In line Grip || TB-545FC: THUNDERBEAT 5 mm, 45 em, Front Actuated Grip || TB-0535FC: THUNDERBEAT 5 mm, 35 em, Front Actuated Grip || The Olympus Thunderbeat Surgical Tissue Management System ("Thunderbeat") is intended to be used for open, laparoscopic (including single-site surgery), and endoscopic surgery to cut (dissect) or coagulate soft tissue or to ligate (seal and cut) vessels.
  • Manufacturer
    Olympus America Inc.

Manufacturer

Olympus America Inc.
  • Dirección del fabricante
    Olympus America Inc., 3500 Corporate Pkwy., P.O. Box 610, Center Valley PA 18034-0610
  • Empresa matriz del fabricante (2017)
    Olympus Corporation
  • Source
    USFDA