Trade name: Aurinio - Trilux Surgical Spotlights. Technical name: Surgical Focus. ANVISA registration number: 10302860156. Hazard class: I. Model affected: SURGICAL FOCUS LED Aurinio L110, L120, L150 and L160 .. Serial numbers affected: 250; 273; 159; 160; 234; 198; 81; 1407; 315; 194; 47; 48; 85; 86; 89; 41; 43; 44; 45; 46; 187; 197; 199; 211 ;. 212; 220; 221; 257; 256; 258; 263. 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 H. Strattner e Cia LTDA; TRILUX MEDICAL GMBH & CO. KG 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
    2528
  • 날짜
    2018-03-28
  • 사례 국가
  • 사례 출처
    ANVISA
  • 사례 출처 URL
  • 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
    In order to avoid risks to patients, users or third parties, the surgical foci should be moved carefully observing the movement limits in the product, avoiding the excess of force against the limits of the structure. Until the corrective measure has been performed, the affected component (elbow) of the dome shall undergo a visual inspection every day to check for cracking. The inspection should be performed around the entire area, if no change is observed, the surgical focus can normally be used until the corrective measure is implemented. If any change is identified, the product should not be used until the correction is made. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (AE) 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: 02/20/2018 - Date of notification notice to Anvisa: 03/22/2018 The company that owns the affected product is responsible for contacting its customers in due time. 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. (...) "
  • 원인
    Through the global monitoring of products, it was possible to identify a possible formation of cracks in the structure supporting the lights of the surgical focus. these cracks can lead to an inability to lift load and, consequently, break the structure.
  • 조치
    Field Action Code TECNOVIG / AC / 01-2018 triggered under the responsibility of the company H. Strattner and Cia LTDA. Parts / parts correction.