Events

Retiro De Equipo (Recall) de Device Recall Olympus OFP Flushing Pump irrigation tubing

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
    60613
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-0806-2012
  • Fecha de inicio del evento
    2011-12-12
  • Fecha de publicación del evento
    2012-01-18
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-09-25
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=105979
  • 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
    Pump, air, non-manual, for endoscope - Product Code FEQ
  • Causa
    Water may leak from the irrigation tubing used on the olympus flushing pump.
  • Acción
    The firm,Olympus, sent an "URGENT-DEVICE CORRECTION " letter dated December 12, 2011 to its customers. The letter described the product, problem and actions to be taken. The customers were informed that any current irrigation tubing in their inventory can be used with the OFP pump; however, they must inspect the tubing installed on the OFP pump for signs of water leakage; if leakage is found, discontinue use of the tubing and replace with a new irrigation tube. In addition, complete and return the enclosed questionnaire via fax to (484) 896-7128. If you do not wish to use your current inventory of irrigation tubing and would like a replacement, call Olympus Customer Care Center at 1-800-848-9024. Olympus is discontinuing the current version of irrigation tubing and has redesigned the irrigation tubing to prevent water leakage. For any additional information, contact the V.P., Regulatory/Clinical Affairs & Quality Assurance at (484) 896-5688 or email at laura.storms-tyler@olympus.com.

Device

Device Recall Olympus OFP Flushing Pump irrigation tubing
  • Modelo / Serial
    Catalog number 7501669
  • Clasificación del producto
    Gastroenterology-Urology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide distribution: USA including states of: AL, AK, AZ, AR, CA, CO, CT, DC, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, AND WY.
  • Descripción del producto
    Olympus OFP Flushing Pump irrigation tubing || The Olympus OFP Flushing Pump is a peristaltic flushing pump intended for use with Olympus gastrointestinal videoscopes having an auxiliary water inlet as part of an Olympus endoscopic imaging system to facilitate washing of gastric and colonic mucosa to remove blood, feces and other organic matter, enabling improved visualization, diagnosis and therapy during endoscopic procedures.
  • 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