Alerte De Sécurité sur Trade Name: Harmonic Ace Shears and Adaptive Tissue Technology. Technical Name: Electrosurgical Cable (Power greater than 50W). ANVISA registration number: 80145901455. Risk Class: III. Model affected: HAR23; HAR36. Affected Serial Numbers: Codes and batch numbers related to each code, for individually marketed affected products, and for kits containing affected products are shown in the Customer Letter attached to this Alert.

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde Ltda.; Ethicon Endo-Surgery LLC.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • ID de l'événement
  • Date
  • Pays de l'événement
  • Source de l'événement
  • URL de la source de l'événement
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    The company that holds the registry recommends the following actions: 1. Inspect the inventory immediately to identify the existence of products subject to this recall; 2. After identification, segregate the units and report the problem to the relevant staff of the surgical or material management center; 3. Fill in the Commercial Response Form (FRC) (Annex 2), confirming receipt of the notice within three (3) business days. 4. Keep the communication in a visible place until all batches of products subject to recall have been returned to the company that holds the record. 5. Immediately return all batches of unused and recalled Scissors that are in your inventory until August 31, 2018. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (EA ) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System ( To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link Complementary Information: - Date of identification of the problem by the company: 09/05/2018 - Date of notification notice to Anvisa: 05/28/2018 The company that owns the affected product is responsible for contacting its customers in a timely manner. to ensure the effectiveness of the Field Action in progress. It stands out the joint responsibility of the distribution chain and use of health products in maintaining its quality, safety and efficacy, as well as the effectiveness of the Field Action, expressed by RDC 23/2012: "(...) Art 2 ° A holder of registration of health product is the holder of the registration / registration of health product with Anvisa. Single paragraph. The registration holder, as well as other agents involved from the production to the use of the product, or discarding it when applicable, are jointly and severally responsible for maintaining the quality, safety and efficacy of the health products to the final consumer. Art. 12 Distributors of health products shall forward to the registration holder, in a timely manner, the distribution map and other information requested for the notification and execution of field actions. (...) "
  • Cause
    According to the company holding the registry, there are some devices contained in the aforementioned lots that were assembled with an internal component that can result in continuous or inadvertent activation of the device. informs that such a situation may cause inadvertent mechanical or thermal damage to the unintentional tissue if continuous or inadvertent activation occurs during surgery.
  • Action
    Field Action Code 1188346 under the responsibility of Johnson & Johnson do Brasil Ind. And Com. De Prod. for Health Ltda. Gathering. Undoing.