Alerta De Seguridad para HARMONIC ACE+ Shears with Adaptive Tissue Technology (23cm and 36cm)

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por Ethicon Endo-Surgery.

¿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
  • Fecha
  • Fecha de publicación del evento
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • Notas / Alertas
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 Hong Kong.
  • Notas adicionales en la data
    Medical Device Safety Alert
  • Causa
    Medical device safety alert: harmonic ace+ shears with adaptive tissue technology (23cm and 36cm) medical device manufacturer, ethicon endo-surgery, has issued a medical device safety alert concerning its harmonic ace+ shears with adaptive tissue technology (23cm and 36cm). the affected devices are identified as the following: product code [lot]: har23 [p9125c, p93t5j, p93t5k, p93v06, p93w0a, p93w4y, p93w8a, p93y4a, p93zax, p93z96, p9400f, p9409v, p94a93, p94a94, p94c8r, p94e6u, p94g1w, p94h32, p94h9v, p94j28]; har36 [n92923, n9392k, p9129w, p91394, p9139n, p9144r, p9148k, p9149j, p9168k, p9173r, p9174k, p91795, p91c51, p91c83, p91f2x, p91k69, p91l0h, p91l1y, p91l6e, p91l6j, p9396a, p9396c, p9399t, p93a1l, p93l47, p93l76, p93m5y, p93m6p, p93m6t, p93n00, p93n01, p93n3x, p93n3y, p93n5a, p93n7h, p93p09, p93p26, p93p2e, p93p7g, p93p7h, p93r0z, p93r10, p93r4f,p93r4g, p93r56, p93r57, p93r6u, p93r6v, p93t0x, p93t20, p93t26, p93t9l, p93u0p, p93u17, p93u5n, p93u90, p93u91, p93v02, p93v03, p93v0v, p93v57, p93v5t, p93w9r, p93w9x, p93x2g, p93x2w, p93x2x, p93x85, p93x98, p93y47, p93y48, p93y8x, p93z4t, p93z5x, p93z95, p94015, p9414t, p94a5k, p94a6a, p94c10, p94c11, p94c47, p94c5r, p94c8t, p94d0m, p94d0p, p94d3j, p94d3k, p94d5g, p94d9k. p94e1z, p94e20, p94e3z, p94e8w, p94f1m, p94f3a, p94f5t, p94f6c, p94f7l, p94g1h, p94g1j, p94h0k, p94h31, p94h4v, p94h8j]. according to the manufacturer, through post-market surveillance efforts and per conducted investigation, it confirmed that some devices contained in these lots may have been assembled with an internal component that may cause continuous or inadvertent activation of the device. the medical assessment concluded that this situation may cause inadvertent mechanical or thermal damage to unintended tissue if the continuous or inadvertent activation occurs when used in operative cases. to date, there are no reports of adverse events associated with the issue that led to this recall. the manufacturer has identified the root cause have implemented immediate corrective actions to address the issue. the affected users are required to: examine their inventory immediately to determine if they have product lots subject to the recall on hand and quarantine such products; remove the product lots subject to the recall and communicate the issue to relevant operating room or materials management personnel, or anyone else in their facility who needs to be informed; and health care practitioners who have treated patients using the affected products should follow those patients post-operatively in the usual manner with no additional action required. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 7 may 2018.


  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: HARMONIC ACE+ Shears with Adaptive Tissue Technology (23cm and 36cm)
  • Manufacturer