Events

Retiro De Equipo (Recall) de Device Recall Pentax Video Duodenoscope

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 Pentax of 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
    77308
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2713-2017
  • Fecha de inicio del evento
    2017-01-17
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2018-03-08
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=155670
  • 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
    duodenoscope and accessories, flexible/rigid - Product Code FDT
  • Causa
    Pentax initiated a field correction/safety alert for two (2) models of the video duodenoscope to determine how soiling may have occurred on the surface of the suction cylinder and under the distal cap during testing.
  • Acción
    The firm, Pentax Medical, sent a "FIELD CORRECTION' letter dated January 17, 2017 to their affected customers via USPS Certified Mail. The letter described the product, problem and actions to be taken. The customers were instructed to immediately remove any affected product from use; follow product labeling; ensure all reprocessing personnel are knowledgeable and thoroughly trained on the instructions of Use for manual reprocessing of the devices; clean elevator recesses and follow all reprocessing instructions; and complete and return the FIELD CORRECTION RESPONSE FORM via a member of the PENTAX Service Department as part of an on-site-visit or Fax to: QA/RA Department at 201-799-4063 (alternate 201-391-4189) or a pdf copy to customeradvisiories@pentaxmedical.com. The firm will replace any affected product with its current generation model. If you have questions or request further information or assistance contact PENTAX Medical Customer Support at 1-800-431-5880 (8:30AM - 5:00PM, Monday-Friday, EST) or email: customeradvisories@pentaxmedical.com.

Device

Device Recall Pentax Video Duodenoscope
  • Modelo / Serial
    Model Numbers: Ed-3490TK and ED-3270K
  • Clasificación del producto
    Gastroenterology-Urology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution-US (Nationwide) including states of: AL, AZ, CA, CO, CT, DC, DE, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MO, MS, MT, NC, NH, NJ, NV, NY, OH, OK, PA, PR, TN, TX, UT, VA, WA, WI, WV, WY;. and country of: CANADA.
  • Descripción del producto
    Video Duodenoscope || These instruments are intended to provide optical visualization of (via a video monitor), and therapeutic access to, the biliary tract via the upper GI tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: esophagus, stomach, duodenum, common bile, hepatic and cystic ducts.
  • Manufacturer
    Pentax of America Inc

Manufacturer

Pentax of America Inc
  • Dirección del fabricante
    Pentax of America Inc, 3 Paragon Dr, Montvale NJ 07645-1782
  • Empresa matriz del fabricante (2017)
    HOYA Corp.
  • Source
    USFDA