Events

Pentax ED-3490TK Video Duodenoscope 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Pentax Medical Pte 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-2017-RN-00120-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-10-16
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00120-1
  • 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
    Pentax medical is informing customers about a potential issue associated with the distal cap of the ed-3490tk and offer recommendations intended to reduce the potential risk for contamination and subsequent patient infection. pentax is also reminding customers to follow the validated manual reprocessing instructions that pentax issued to all pentax model ed-3490tk duodenoscope customers in april 2016. this action was undertaken prior to consultation with the therapeutic goods administration (tga).
  • 조치
    Pentax is advising users that the validated manual reprocessing procedures included in the current Instructions for Use (RIFU 6217001 S059 R01, April 2016) remain the same. PENTAX reminds its customers of the importance of using the ED-3490TK according to its current labelling. Customers must ensure that all reprocessing personnel are knowledgeable and thoroughly trained on the current Instructions for Use for manual reprocessing of these devices. Meticulous cleaning of the elevator recesses and attention to following all reprocessing instructions are required. Additionally, PENTAX recommends that users immediately remove from use any ED-3490TK duodenoscope that shows visible signs of wear or physical damage. PENTAX will provide annual inspection and servicing to all customers with ED-3490TK duodenoscopes. During on-site inspections, PENTAX fie

Device

Pentax ED-3490TK Video Duodenoscope
  • 모델명 / 제조번호(시리얼번호)
    Pentax ED-3490TK Video DuodenoscopeARTG Number: 234951
  • Manufacturer
    Pentax Medical Pte Ltd

Manufacturer

Pentax Medical Pte Ltd
  • Source
    DHTGA