Events

Retiro De Equipo (Recall) de Device Recall Broncho Flexible Fiberscope

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 Karl Storz Endoscopy 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
    66862
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0527-2014
  • Fecha de inicio del evento
    2013-11-13
  • Fecha de publicación del evento
    2013-12-17
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-03-27
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=123807
  • 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
    Nasopharyngoscope (flexible or rigid) - Product Code ECQ
  • Causa
    Karl storz endoscopy america, inc. is recalling the flexible broncho fiberscope or a flexible intubation fiberscope with a suction port because the material used in the suction channel portion was thermoplastic polyurethane (tpu), which is not listed in sterrad systems claims for interior endoscope lumens.
  • Acción
    The firm, KARL STORZ, sent a "A SAFETY ALERT-ATTENTION NEEDED" letter dated November 8, 2013 to all their customers on November 13, 2013. The letter describes the product, problem and actions to be taken.The letter informs the customers that the endoscopes incorporated a lumen material that is only approved for use as an external surface material and not included in the STERRAD NX and 100NX FDA-cleared claims for use in flexible endoscope lumens. The customers were instructed to follow the recommended processing methods included in the letter. Customers with questions about the letter are instructed to contact the undersigned and the Technical Services at (800) 421-0837, ext 5350.

Device

Device Recall Broncho Flexible Fiberscope
  • Modelo / Serial
    C1140, C1140E, C1160, C1160E, QKC1750, QKC1750E, QKC1694, QKC1694E
  • Clasificación del producto
    Dental Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution.
  • Descripción del producto
    Broncho Flexible Fiberscope, models: 11001BN1, 11002BD1, 11004BC1, and 11009BC1. || " Examination and treatment of the tracheobronchial tree Contraindications for Bronchoscopy " Uncontrolled angina, uncontrolled heart failure, or serious uncontrolled ventricular arrhythmias " Uncontrolled hypertension " Bleeding disorder or use of anticoagulants.
  • Manufacturer
    Karl Storz Endoscopy America Inc

Manufacturer

Karl Storz Endoscopy America Inc
  • Dirección del fabricante
    Karl Storz Endoscopy America Inc, 15 Wells St, Southbridge MA 01550-4503
  • Empresa matriz del fabricante (2017)
    Karl Storz SE & Co. KG
  • Source
    USFDA