Events

10mm 0Deg Infrared Telescope and 10mm 30Deg Infrared Telescope10mm 0Deg Infrared Telescope 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Olympus Australia Pty Ltd 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    RC-2018-RN-00841-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2018-07-02
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00841-1
  • 비고 / 경고
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • 데이터 추가 비고
  • 원인
    The manufacturer olympus winter & ibe has updated section 7.9.1 gas sterilisation in the instructions for use for the wair100a and wair130a to include the following warning:“warningrisk of injury to the patient and usertoxic gasses can enter internal volumes of the product during gas sterilisation. the gasses can remain in the product and can leak out during use.· to remove toxic gasses, aerate the product sufficiently after sterilisation.”.
  • 조치
    Olympus is requesting users: 1. Inspect their inventory for any WAIR100A or WAIR130A Infrared Telescopes within their control; 2. Remove any existing Instructions for Use (IFU) and implement use of the updated IFU; 3. Ensure all reprocessing personnel are informed of the additional warning. Please do not hesitate to contact your local Olympus Sales Specialist to organise additional training; 4. Complete the reply form supplied with the customer letter and email to RA@Olympus.com.au or fax to 03 9562 6438; and 5. If you have distributed or transferred any of the affected products from your facility to another, forward the recall letter to them and notify Olympus so that they can follow up with that facility directly.

Device

10mm 0Deg Infrared Telescope and 10mm 30Deg Infrared Telescope10mm 0Deg Infrared Telescope
  • 모델명 / 제조번호(시리얼번호)
    10mm 0Deg Infrared Telescope and 10mm 30Deg Infrared Telescope10mm 0Deg Infrared TelescopeModel Number: WAIR100A10mm 30Deg Infrared TelescopeModel Number: WAIR130AAll Lot/Serial NumbersARTG Number: 146202(Olympus Australia Pty Ltd - Endoscope element, telescope)
  • Manufacturer
    Olympus Australia Pty Ltd

Manufacturer

Olympus Australia Pty Ltd