Events

Alerta De Seguridad para Trade Name: ELECTROCIRUTIVE UNIT Technical Name: Electrosurgical Unit for Cutting and Coagulation ANVISA Registration Number: 80102511581 Hazard Class: III Model Affected: HYFRECATOR 2000 Affected Lot / Serial Numbers: 16181400; 16,181,401; 16,181,402; 16,181,403; 16231692; 16231694; 16231701; 16231703; 16,181,404; 16231704; 16181406

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por VR MEDICAL IMPORTADORA E DISTRIBUIDORA DE PRODUTOS MÉDICOS LTDA; CONMED CORPORATION.

¿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
    2246
  • Fecha
    2017-03-23
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • 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
    Collection lots must be removed from your inventory and returned to the supplier as soon as possible.
  • Causa
    Electrosurgical hyfrecator® 2000 units are sold as non-sterile and reusable devices. a separate accessory package is included in each hyfrecator® 2000 electrosurgical (esu) box. this accessory pack contains 2 sterile handpiece sheaths, p / n 7-796-19. from december 2, 2015 through january 3, 2017, the accessory packs on the hyfrecator® 2000 seu cards were packaged by the manufacturer with the non-sterile parts sheets p / n 7-796-19 in pouches that were labeled as "sterile." this may lead an end-user to use a non-sterile sheath as if it were sterile. conmed and vr medical have not received any reports that this labeling error has resulted in disease or injury.
  • Acción
    Field Action Code AC005-17 triggered under the responsibility of the company VR MEDICAL IMPORTADORA E DISTRIBUIDORA DE PRODUTOS MÉDICOS LTDA. Company will collect.

Device

Trade Name: ELECTROCIRUTIVE UNIT Technical Name: Electrosurgical Unit for Cutting and Coagulation...

Manufacturer

VR MEDICAL IMPORTADORA E DISTRIBUIDORA DE PRODUTOS MÉDICOS LTDA; CONMED CORPORATION
  • Source
    ANVSANVISA