Events

Alerte De Sécurité sur Trade name: FS-14 Double Pedal component of the HF-120 / SS 200-E models. Technical name: Microprocessed Electronic Scalpel. ANVISA registration number: 10247670035. Risk class: III. Model affected: HF-120 / SS 200-E. Serial number affected: 8020140101; 8020950101; 8025670101; 8003380101; 8017000101; 8003040101

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 WEM Equipamentos Eletronicos Ltda.

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
    2508
  • Date
    2018-03-12
  • Pays de l'événement
    Brazil
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • 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
    1. Quarantine and discontinue use of affected pedals (batches listed above) 2. Replace pedals affected by new pedal shipped by the company 3. Return affected pedal (model FS-14) to WEM representative of your region If you want 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 Additional information: - Date of identification of the problem by the company: 11/21/2018 - Date of notification notice to Anvisa: 03/02/2018 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
    The fs-14 double pedal - code 04728 (accessory of the hf-120 and ss-200e microprocessed electronic bistables) was marketed outside the specification. the functional failure of the pedal reverses the function activated. the pedal connected to the electro-surgical generator when activated provides an inverse response to the requested one. when the coagulation function is activated, the equipment performs the cut and when the cut function is activated, the equipment performs coagulation.
  • Action
    Field Action Code R201611-09 triggered under the responsibility of the company WEM Equipamentos Eletronicos Ltda. Will make recollection

Device

Trade name: FS-14 Double Pedal component of the HF-120 / SS 200-E models. Technical name: Micropr...

Manufacturer

WEM Equipamentos Eletronicos Ltda
  • Société-mère du fabricant (2017)
    Medtronic plc
  • Commentaire du fabricant
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    ANVSANVISA