Events

AMPLITUDE Orthopaedic Surgical Instruments 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Amplitude 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-2014-RN-01059-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2014-10-03
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01059-1
  • 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
    Amplitude identified an error regarding the automated cleaning process in the instructions for use (ref. no103 indices j, k and l) supplied with its surgical instruments since 2012. the protocol is not the correct one and does not correspond to the validated cycle, although it is applicable for the universal handle (ref. 2-0232100). the automated cleaning (washer - disinfector step) in the ifu incorrectly states to process in a solution of alkaline detergent (e.G. 5% mediclean) for 15 minutes at 40°c. the correct procedure is to process in a solution of alkaline detergent (e.G. 0.5% mediclean) for 10 minutes at 93°c.
  • 조치
    A copy of the revised Instructions For Use NO103 – revision M is attached with the customer letter. Amplitude is asking the customers to verify the automated cleaning parameters in the revised instructions for all other Amplitude instruments (except the universal handle). This action has been closed-out on 18/03/2016.

Device

AMPLITUDE Orthopaedic Surgical Instruments
  • 모델명 / 제조번호(시리얼번호)
    AMPLITUDE Orthopaedic Surgical Instruments ARTG Number: 178179
  • Manufacturer
    Amplitude Australia Pty Ltd

Manufacturer

Amplitude Australia Pty Ltd