Events

Product: ULTRASONIC SYSTEM CUSA. Registration: 10099430147. CEM Nosecones (C6623 or C6626) with CUSA Excel / Excel + Ultrasonic Aspirator 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 INTEGRA LIFESCIENCE LIMITED; INTEGRA LIFESCIENCES CORPORATION 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
    1227
  • 날짜
    2013-01-17
  • 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 that holds the registration in Brazil has notified this ANVISA.
  • 원인
    Since 2009, integra has received a small number of cusa tip breaking claims. none of these claims resulted in patient harm or any adverse health consequences. research has been carried out and it has been identified that these tips are used in some specific circumstances with nosecone cem and there is a potential chance of wear of the cusa tip. this potential wear can lead to tip breakage. specifically, the wear potential of cusa occurs during the emc operation specifically at the contact between the tip side and the fabric, when this contact should occur only between the tip and the fabric.
  • 조치
    The company has sent a letter (Medical Device Safety Notice) (Annex) to its customers informing them of the problem and is in the process of reviewing the Instructions for Use of the Product (Annex). http://en.wikipedia.org/w/eng/index.php/

Device

Product: ULTRASONIC SYSTEM CUSA. Registration: 10099430147. CEM Nosecones (C6623 or C6626) with C...

Manufacturer

INTEGRA LIFESCIENCE LIMITED; INTEGRA LIFESCIENCES CORPORATION