Events

Retiro De Equipo (Recall) de Device Recall AppleHunt Secondary Cannula/Pyramidal Tip Trocar

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 CooperSurgical, 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
    79825
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1584-2018
  • Fecha de inicio del evento
    2018-03-12
  • 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=163601
  • 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
    Trocar - Product Code DRC
  • Causa
    Products have been packaged with the wrong trocar length type.
  • Acción
    On March 26, 2018 CopperSurgical Inc. mailed a Medical Device Recall Notification to affected customers. Customers were instructed to discontinue the use of the affected lot number 223333 and complete an Acknowledgement and Receipt Form to schedule refund or exchanges. If customers supplied products to any other facility, they have been asked to provide the recipients a copy of the notification letter. Customers with questions may contact CopperSurgical at recall@coopersurgical.com.

Device

Device Recall AppleHunt Secondary Cannula/Pyramidal Tip Trocar
  • Modelo / Serial
    Lot number 223333
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US Nationwide in the states of FL, GA, IN, NJ, and countries of Canada, Austria, Chile, Italy, Singapore
  • Descripción del producto
    5 mm Apple-Hunt Secondary Cannula/Pyramidal Tip Trocar - extended length (5 count); Model Number 900-840 || Product Usage: || The Apple-Hunt Secondary Cannulas are indicated for use in laparoscopic surgical procedures to provide a pathway for the introduction of endoscopic surgical instruments and allow for maintenance of pneumoperitoneum. For uninhibited laparoscopic access, the Apple-Hunt Cannula/Trocar provides greater instrument maneuverability while maintaining an airtight seal -with no bulky external valves, fittings, or housings. The ergonomic trocar design is simple to use and features a smooth cannula/trocar transition for easier sleeve insertion and reduced risk of patient injury.
  • Manufacturer
    CooperSurgical, Inc.

Manufacturer

CooperSurgical, Inc.
  • Dirección del fabricante
    CooperSurgical, Inc., 95 Corporate Dr, Trumbull CT 06611-1350
  • Empresa matriz del fabricante (2017)
    The Cooper Companies, Inc.
  • Source
    USFDA