Alerta De Seguridad para Trade name: Instrument Kit for Orthopedic Surgery - ANKLE NEW DEAL; ANVISA registration number: 80043770018; Risk class: I; Affected model (s): 109 900, 109 901 and 109 902.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por PER PRIMA COMERCIO E REPRESENTAÇÕES LTDA.; NEWDEAL SAS.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • ID del evento
    1866
  • Fecha
    2016-03-28
  • País del evento
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
  • Notas / Alertas
    Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
  • Notas adicionales en la data
    User and Patient Orientation: Prior to steam sterilization, the five above-mentioned devices, available in the FOREFOOT 1.5 set, must be OPEN, MISSED, AND CHANGED ACCORDING TO THE INSTRUMENTS BELOW. Additionally, a component needs to be inserted in the Uni-Clip® magnification forceps reference: 119311, of the FOREFOOT 1.5 set. This component is a metal ring (part number 119311R) that slides into the gripper grips to keep them in the open position during sterilization. This precaution is effective to ensure the sterility assurance level of 10-6 for the following sterilization parameters in the autoclave pre-vacuum stage: Option 1: temperature 134 ° C, cycle 18 minutes; drying 20 minutes Option 2: temperature 134 ° C, cycle 3 minutes; drying 20 minutes OBS .: We hereby clarify that the metal ring code 119311R will be included in the ANVISA 80043770014 - Instrumentation Kit for Orthopedic Surgery - NEWDEAL FOOT, as well as the reprocessing recommendations. Until the approval of ANVISA, the FOREFOOT INSTRUMENTATION SET 1.5 should be segregated.
  • Causa
    Through internal study, the manufacturer determined that the recommended sterilization cycle in the reprocessing instruction for the forefoot 1.5 set did not provide the level of sterility safety recommended by en556-1 for the five devices mentioned above and contained on set forefoot 1.5. the registry holder states that to date there have been no reports of a patient injury or other adverse consequence related to this concern for the affected instruments. incorrect sterilization has the potential to contribute to the transmission of infectious and non-infectious agents.
  • Acción
    Action code 1. Recommendations to users and patients.