Events

Endoscopic Linear Cutter Reload, Black, Record no. 80145900883. Range of expiration date affected: 05-2013 to 03-2014. Lots: See attachment 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
    1287
  • 날짜
    2013-05-29
  • 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 reports that the event found may result in insufficient tissue apposition and may require surgical intervention to help achieve and maintain anastomotic integrity. To date, the company is not aware of any potential complications that have occurred as a result of this event
  • 원인
    The registrant reports that ethicon endo-surgery is initiating a voluntary recall of batches listed in the annex due to potential for incomplete stapling line formation caused by damage to recharge during the firing sequence.
  • 조치
    The company provided the following guidance: 1. Inspect your inventory immediately to verify that you have the affected product manufactured by Ethicon and remove it from the stock (see attachment). 2. Fill out the Business Response Form (BRF) and fax to the local company within 11 working days, even if you do not have the product affected. The company requests that you mention Event 4706. If you have any product to be returned, keep a copy of this form in your records. The replacement product will be shipped in lieu of all recalled products that are returned. 3. All affected products must be returned by August 30, 2013 to receive the replacement product. To return the affected product, take a xerox copy of the completed Business Response Form, put it in the box along with your product. 4. The ECHELON 60mm Black Reload (ECR60T) products will be replaced by the corrected ECHELON 60mm Black Reload (ECR60T) as soon as the supply is made available. 5. If you do not have the affected product in inventory, you must still complete and return the Business Response Form, stating that you do not have any affected products. 6. We ask that you share this information with all appropriate personnel at your facility. 7. If you need assistance identifying an alternate product code, please contact your Ethicon Sales Representative directly.

Device

Endoscopic Linear Cutter Reload, Black, Record no. 80145900883. Range of expiration date affected...

Manufacturer

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