Events

Endowrist Instruments and Accessories for the da Vinci Surgical Systems (Used in endoscopic procedures) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Device Technologies 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-2013-RN-00890-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2013-08-22
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00890-1
  • 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
    Device technologies australia are implementing a revised reprocessing instructions for endowrist instruments and accessories.The changes include:- to allow the use of mildly alkaline enzymatic cleaners, instead of only ph-neutral enzymatic cleaners.- to clarify soaking prior to active scrubbing and rinsing in order to soften soil and make pre-cleaning easier.- to augment scrubbing by spraying water through the isi-supplier luer nozzle at 2 bar pressure onto the tip of the instrument.- to add magnification to the visual inspection of instruments to make it easier to ensure that instruments are free of visible soil prior to automated reprocessing.
  • 조치
    Device Technologies Australia is providing on site training for the revised instructions, review updated content and provide a Cleaning and Sanitation kit (including the revised instructions) for all users.

Device

Endowrist Instruments and Accessories for the da Vinci Surgical Systems (Used in endoscopic proce...
  • 모델명 / 제조번호(시리얼번호)
    Endowrist Instruments and Accessories for the da Vinci Surgical Systems (Used in endoscopic procedures)Part Numbers of Affected Reprocessing Instructions: 550874-02 and 550882-05ARTG Number: 132451
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd