Events

Safety Alert for ASSEMBLY OF PRODUCTS FOR BARIATRIC SURGERY PER VIDEO, Model Kit pleased: Kit containing: 1 Tesouta curve HARMONIC ACE (ACE36E); 5 45mm Blue Recharge for ETS Stapler (6R45B); 1 ETS-Flex45 endoscopic, linear, non-refillable stapler (ATS45); 1 xcell endopath trocar without 11mm blade (B11LT); 1 xcell endopath trocar without 12mm blade (B12LT); 1 xcell endopath trocar without 5mm blade (B5LT); 2 Endoclath xcel single cannula for 12mm trocarte (CB12LT); 1 Endopath xcel single cannula for trocarte 5mm (CB5LT); 2 Load 45mm for ETS Stapler, White - Vascular Tissue (TR45W). Registration nº 80145901358, Product code XBB44B, lots available in Brazil K4CZ99 and K4D08Z.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde Ltda.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    1353
  • Date
    2014-02-03
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    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.
  • Extra notes in the data
    The company informs that this type of failure can be identified by the user before use. There are no health consequences that can have significant impacts on public health beyond immediate users. Still, there are no indirect health consequences as a result of the aforementioned event. If the GEN11 equipment is used, no quality deviation is expected. If the GEN04 generator is used, the manual activation of the device will not be observed before use.
  • Reason
    The company has received customer reports describing that the xbb44b (bariatric video surgery product suite) product presents a discrepancy in etiquette and content. the johnson & johnson medical brazil nationalization label indicates that this kit contains the product code ace36e, however, it contains the product identified under code har36, which is duly registered with anvisa under no. 80145901455. the identification of the assembly ( xbb44b) and its configuration are not properly registered with anvisa. and the har36 code is not compatible with the gen04 generator.
  • Action
    The company directs you to: 1. Examine your inventory immediately to determine if you have the affected product that was manufactured by Ethicon and remove it. See Appendix A for assistance in identifying the affected product. 2. Complete the Commercial Response Form (Attachment B), send it to the fax: (011) 3030 1109 or e-mail: pcunha1@its.jnj.com. If you have a product to be returned, keep a copy of this form in your records. 3. All affected products must be returned by April 1, 2014. To return the affected product, make a copy of the completed form, place it in the box with the affected product, and contact us at (11) 3030 1289 (Patricia) or 3030 1032 (Juliana) for more details on the return procedure. 4. Even if you do not have the affected product in your inventory, please complete the fields on the business response form and send it to our company indicating that you do not have the affected products. 5. Please share this information with all the staff involved in your establishment. 6. If you need assistance identifying an alternate product code, please contact our Johnson & Johnson Medical sales representative directly.

Device

ASSEMBLY OF PRODUCTS FOR BARIATRIC SURGERY PER VIDEO, Model Kit pleased: Kit containing: 1 Tesout...

Manufacturer

Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde Ltda