Events

translation missing: ko.activerecord.attributes.event.titles.recall_field_safety_notice

Saudi Food & Drug Authority에 따르면, 해당 translation missing: ko.activerecord.attributes.event.types.recall_field_safety_notice 는 Saudi Arabia 에서 Intuitive Surgical Inc 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

현장 안전성 서한은 의료기기 제조사 또는 제조사 대리인이 시중에 유통되고 있는 자사 의료기기 제품에 대하여 취할 수 있는 조치를 알리는 소통방식입니다. 주요 대상층은 보건의료업계 종사자와 의료기기 사용자들입니다. 여기에는 회수(recall) 조치와 경고도 포함될 수 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall / Field Safety Notice
  • 사례 ID
    mdprc 056 10 13 000
  • 사례 시작날짜
    2013-10-10
  • 사례 국가
    Saudi Arabia
  • 사례 출처
    SFDA
  • 사례 출처 URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=5&rid=4494
  • 비고 / 경고
    Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 recall data from the U.S. and Saudi Arabia.
  • 데이터 추가 비고
    Report Source: NCAR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • 원인
    A review of internal records has indicated that from march 15th to july 19th 2013, the correct user manual associated with the single-site® instruments, specifically the bipolar maryland and curved needle driver instruments, was not distributed to customers prior to shipment and use of the instruments. this correction does not impact the performance of the affected instruments and no product removal is required. the actual risk of use of the new instruments without the correct documentation is minimal as the same or similar content is included with the is3000 instruments and accessories user manual as well as the single-site® marketing materials.

Device

Single use , Endotherapy electrosurgical diathermy system electrode . Bipolar Maryland
  • 모델명 / 제조번호(시리얼번호)
    Product Number/Catalog Number : 428080-04 , 428088-12 from 15 March through 19 July 2013
  • 제품 설명
    Single use , Endotherapy electrosurgical diathermy system electrode . Bipolar Maryland
  • Manufacturer
    Intuitive Surgical Inc

Manufacturer

Intuitive Surgical Inc