Events

Alerta De Seguridad para Electrosurgical Unit HARMONIC ACE +7 SHEARS WITH ADVANCED HEMOSTASIS, register - 80145901510 - Model HARH23 - Lots: L92G7W; L92R3H; L92U7M; L92Y2K; L92Y5M; M9029F; M91M8D; M91P44; M91T75; M92303; M9232T; - Model HARH36: Lots: L92T2A; L92T64; L92T6X; L92X1Z; L92X73; L92Y9L; L92Z7H; L9307C; L9311H; L9330R; L9339Z; L9362R; L9362Z; M90494; M9051C; M90A5M; M90C87; M90N7V; M90U35; M90V91; M90W6F; M90X4P; M90Y2N; M9127U; M91398; M9143P; M9155F; M9180E; M91950; M91A3L; - Model HARH4: Lots: L92J40; L92L1C; L92X6G; L93426; M9007F; M90138; M9024R; M9030N

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde Ltda; Ethicon Endo-Surgery, LLC.

¿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
    1724
  • Fecha
    2015-10-30
  • 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
    The company informs that if the product is used with compromised sterility, pathogens can be introduced into the patient causing infection. The populations most at risk would be immunocompromised patients, the pediatric population, the elderly, people with significant morbidities, such as diabetes, and those in certain medical therapies
  • Causa
    Ethicon has detected that, under extreme handling conditions, damage, such as a hole, may occur in the tyvek® cap. the root cause has been identified as an interaction between the advanced hemostasis button (green) and the tyvek® cap which, under extreme handling conditions, could damage the tyvek® cap resulting in a breach of sterility. the harmonic ace® + 7 product is marketed and identified as "sterile" and the integrity of the packaging is essential to ensure sterility. the product and the package have been subjected to standard transport tests and have met the requirements. as part of the root cause investigation, it has been identified that if the packed device is thrown from an excessively high height during transit, a hole can be created in the tyvek® cap.
  • Acción
    The product should have its use suspended and returned to the company. There are products with similar functions available in the market as the coagulating shears of models HAR23, HAR36 and ACE45.

Device

Electrosurgical Unit HARMONIC ACE +7 SHEARS WITH ADVANCED HEMOSTASIS, register - 80145901510 - Mo...

Manufacturer

Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde Ltda; Ethicon Endo-Surgery, LLC