Events

Trade name: GDC 360 °. Registration number ANVISA: 80005430270. Class of risk: IV - Maximum risk. Affected models / lots: - Model: M0033471020SR0, lots: 17328407, 17581672, 18617200; - Model: M00334811300, lots: 17735100, 17818842. 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Stryker do Brasil Ltda; Stryker Neurovascular - Business and Technology Park 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
    1912
  • 날짜
    2016-04-11
  • 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
    There is no increased risk for users or patients. The most likely effect of incorrect DFU placement on the box is customer dissatisfaction. The most serious clinical effect for the patient is insignificant, which is the prolongation of the procedure. If the physician were to check the DFU for additional information and view the GDC DFU instead of the GDC 360 DFU, it is likely that another device will be used or the procedure will be prolonged.
  • 원인
    There is a potential risk that the gdc 360 springs, from the referenced batches, have been packaged together with the incorrect use statement (dfu). this discrepancy affected only these products. products affected by this field action were correctly labeled (product name, size and etc.). given this, the indications of use, instructions, device function, precautions and precautions associated with the use of the device for the gdc is equivalent to the gdc 360, there are no predictable factors that contribute to product risks. the gdc and gdc 360 springs have the same intended use, the same warnings and precautions, and even mode of operation. the difference is in the name and referring to the shape of the spring. the choice of spring is based on the physician's preference. there are no specific instructions in the dfu (instruction of use) regarding the selection of spring shape or use. the label on the packaging is correct and is the main source of information for choosing the device including the size of the device and shape. the device is intact and expected performance as well. there is no increased risk for users or patients. the most likely effect of incorrect dfu placement on the box is customer dissatisfaction. the most serious clinical effect for the patient is insignificant, which is the prolongation of the procedure. if the physician were to check the dfu for additional information and view the gdc dfu instead of the gdc 360 dfu, it is likely that another device will be used or the procedure will be prolonged.
  • 조치
    Distributors of affected lots should, according to the company Stryker do Brasil Ltda - CNPJ 02.966.317 / 0001-02, "print out and adapt the DFU (Instructions for Use) before distributing this item. It is not necessary to return this item to Stryker. "Correction of Instructions for Use Code RA2016-036

Device

Trade name: GDC 360 °. Registration number ANVISA: 80005430270. Class of risk: IV - Maximum risk....

Manufacturer

Stryker do Brasil Ltda; Stryker Neurovascular - Business and Technology Park
  • 제조사 모회사 (2017)
    Stryker
  • Source
    ANVSANVISA