Events

Retiro De Equipo (Recall) de Device Recall Precision Bipolar Device

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 Datascope 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
    38005
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1158-2007
  • Fecha de inicio del evento
    2007-05-07
  • Fecha de publicación del evento
    2007-08-09
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2008-03-04
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=52712
  • 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
    endoscopic vessel harvesting system - Product Code GEI
  • Causa
    Datascope has experienced a higher than usual number of reports involving the precision bipolar device. reports include the locking or sticking of the buttons of the device which operate the jaws, particularly when a side load is placed on the shaft of the device.
  • Acción
    Letters were sent to all hospitals, (contact: Hospital Administrators) the week of May 7, 2007 (certified mail, Return Receipt requested) with Urgent Medical Device Field Correction. The letter requests that all potential users of the devices at the institution be mdae aware of the situation. The letter instructs clinicians what to do if they experience problems with locking buttons of the Precision Device and also if the device is clamped closed on a vein branch and cannot be opened. Institutions are also requested to sign and return a postal card acknowledging receipt of the Field Correct notification and Datascope provides telephone numbers for customer service.

Device

Device Recall Precision Bipolar Device
  • Modelo / Serial
    Part number PBD01 Lot number 12517, Exp. 5/13/09; 12512m
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide, including USA, Belgium, the Netherlands, and Germany.
  • Descripción del producto
    Precision Bipolar Device 6 pack || Consists of a six-pack of the Precision Bipolar Device. || Manufactured for: || Datascope Cardiac Assist || 15 Law Drive || Fairfield, NJ 07004-0011
  • Manufacturer
    Datascope Corporation

Manufacturer

Datascope Corporation
  • Dirección del fabricante
    Datascope Corporation, 15 Law Dr, Fairfield NJ 07004-0011
  • Empresa matriz del fabricante (2017)
    Getinge AB
  • Source
    USFDA