Events

Retiro De Equipo (Recall) de Device Recall DSD Application Guide (MG040001 revision M) for Pentax Universal Video Scope Hookup:DSD110HU0109

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 Minntech Corp.

¿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
    56189
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2213-2010
  • Fecha de inicio del evento
    2010-06-15
  • Fecha de publicación del evento
    2010-08-12
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-12-17
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=92897
  • 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
    Accessories, cleaning, for endoscope - Product Code FEB
  • Causa
    The dsd hook up application guide incorrectly recommends use of the medivators dsd-110-hu0109 endoscope hookup to connect the pentax eg-3630u ultrasound endoscope to a medivators dsd endoscope reprocessor or medivators scope buddy endoscope flushing aid. this may result in inadequate disinfection during reprocessing, and subsequent infection risk to the patient. the recall was due to the misprinte.
  • Acción
    Consignees were sent a Medivators Reprocessing Systems "Urgent Medical Device Recall" letter date June 17, 2010. The letter was addressed to "Dear Medivators Customers". The letter described the problem and product involved. Recommended consignees to immediately examine the Pentax EG-3630U Ultrasound Endoscope hookups and inform all staff of the notice to ensure that the DSD-11--HU01109 is not used with the Pentax endoscope. Also requested consignees to complete and return the enclosed response form.

Device

Device Recall DSD Application Guide (MG040001 revision M) for Pentax Universal Video Scope Hooku...
  • Modelo / Serial
    A lot number listing is not applicable as this is a field correction of the labeling. The 0109 hookup itself is not defective and can still be used safely with other enodscopes.
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    AZ, AR, CA, CT, DE, FL, GA, ID, IL, IN, KS, KY, LA, MD, MA, MI, MN, MS, MO, NH, NJ, NY, NC, ND, OH, PA, SC, TN, TX, UT, VA, WA, WV, WI, WY.
  • Descripción del producto
    DSD Application Guide (MG04-0001 revision M) for the Pentax Universal Video Scope Hookup (DSD-110-HU0109) only when used with the DSD automated endoscope reprocessor (AER) and the Pentax EG-3630U endoscope.
  • Manufacturer
    Minntech Corp

Manufacturer

Minntech Corp
  • Dirección del fabricante
    Minntech Corp, 14605 28th Ave N, Plymouth MN 55447-4822
  • Source
    USFDA