Events

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. 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde Ltda 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

안전성 경고는 의료기기 제품과 관련된 중요한 정보와 권고사항을 담고 있습니다. 물론 안전성 경고가 배포되었다고 해서 해당 제품이 무조건 안전하지 않은 제품이라는 것은 아닙니다. 보건의료업계 종사자와 의료기기 사용자들에게 배포되는 안전성 경고에는 회수(recall)도 포함될 수 있습니다. 제조사가 안전성 경고를 작성하기도 하지만, 보건당국에서 작성하는 경우도 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Safety alert
  • 사례 ID
    1353
  • 날짜
    2014-02-03
  • 사례 국가
    Brazil
  • 사례 출처
    ANVISA
  • 사례 출처 URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • 비고 / 경고
    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.
  • 데이터 추가 비고
    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.
  • 원인
    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.
  • 조치
    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