Events

Burr hole probe cover with gel 를 위한 안전성 경고 / 현장 안전성 서한

Medicines and Healthcare products Regulatory Agency에 따르면, 해당 안전성 경고 / 현장 안전성 서한 는 United Kingdom 에서 Microtek Medical Europe 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
    Safety alert / Field Safety Notice
  • 사례 ID
    MDA/2013/076
  • 사례 연번
    CON329263
  • 날짜
    2013-10-24
  • 사례 출판 날짜
    2013-10-24
  • 사례 국가
    United Kingdom
  • 사례 출처
    MHRA
  • 사례 출처 URL
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON329263?tabName=allTabs
  • 비고 / 경고
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 the United Kingdom.
  • 데이터 추가 비고
  • 원인
    Risk of exposure to endotoxin levels above acceptable limits if the ultrasound probe cover comes into contact with the central nervous system. the manufacturer has identified that the affected ultrasound probe covers have not undergone adequate endotoxin testing. microtek medical europe issued a field safety notice (fsn) dated 10 july 2013 but has not received sufficient confirmation from users that they have received and acted on this information.
  • 조치
    Ensure that relevant staff are aware of this Field Safety Notice. Identify all affected batches of these ultrasound probe covers. Quarantine all affected batches. Complete the recall response form and return it to Microtek Medical Europe as soon as possible. Follow the manufacturer’s instructions for returning the affected devices. Action by: Operating theatre staff and surgical staff Neurosurgery departments Spinal surgery departments Radiology departments Supplies departments

Device

Burr hole probe cover with gel
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Ultrasound probe cover: Burr hole probe cover with gel. These ultrasound probe covers are disposable, single-use drapes. They are used as a cover for ultrasound probe scan heads and power cords, used for various surgical procedures, to provide a barrier over the equipment. Product reference (SKU number): 3688UK, PC3688, PC3688EU. Affected batch numbers are listed in the Field Safety Notice (FSN). Note that product ref (SKU number) 3688 is listed in the FSN but it is not for sale in the UK.
  • Manufacturer
    Microtek Medical Europe

Manufacturer

Microtek Medical Europe