Events

Retiro De Equipo (Recall) de VIPA IntraFiberoptic Pelvic Assistant

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 Marina Medical Instruments 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
    53501
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1206-2010
  • Fecha de inicio del evento
    2009-04-09
  • Fecha de publicación del evento
    2010-03-25
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-09-03
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=85658
  • 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
    Probe, Rectal, Non-Powered - Product Code EXX
  • Causa
    Marina medical, sunrise, fl initiated recall of 46 different 350 series devices and 47 different 270 series products because the material used to manufacture the products was not proven to be biocompatible, resulting in risk of temporary skin or tissue irritation.
  • Acción
    A "PRODUCT RECALL NOTICE" letter dated April 8, 2009, was sent to the customers. The letter describes the product, problem and the action to be taken by the customers. The customers are asked to identify the subject part in their instrument inventory and quarantine it. The Quality Control team at Marina Medical will contact the customer with instructions to return the part. When contacted, the customer should report any incidents of adverse reactions that have been observed at their institution. If you have any questions, please call 1-800-697-1119 ore (954) 924-4418.

Device

VIPA IntraFiberoptic Pelvic Assistant
  • Modelo / Serial
    KIT Catalog No. 350-370 Individually Catalog No 350-374; 350-375; 350-376; 350-378; 350-380; 350-372.
  • Clasificación del producto
    Gastroenterology-Urology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide distribution.
  • Descripción del producto
    VIPA Veronikis Intra-Fiberoptic Pelvic Assistant, Set Catalog No 350-370. || VIPA Set Includes: || VIPA Urethropexy Tip Catalog No. 350-374 (Also sold individually); || VIPA Urethropexy Elbow Catalog No. 350-375 (also sold individually); || VIPA Vaginal Cuff Tips (small) Catalog No. 350-376 (Also sold individually); || VIPA Vaginal Cuff Tips (large) Catalog No. 350-378 (Also sold individually); || VIPA Rectal Probe Catalog No. 350-380 (Also sold Individually); || VIPA Fiber Optic Cable (Storz to ACMI Connection) Catalog No. 350-372 (Also sold individually). || For use in Urethropexy Procedures and Paravaginal Repairs (accurate suture placement by illuminating the anatomy lateral to the bladder neck); in Sacrocolpopexy (steadies the vaginal vault and provides a suture platform with fiberoptic illumination); in Vaginal surgery (illuminates the rectum to visualize endometriosis lesions on the rectovaginal septum).
  • Manufacturer
    Marina Medical Instruments Inc.

Manufacturer

Marina Medical Instruments Inc.
  • Dirección del fabricante
    Marina Medical Instruments Inc., 955 Shotgun Rd, Sunrise FL 33326-1964
  • Empresa matriz del fabricante (2017)
    Marina Medical Instruments Inc.
  • Source
    USFDA