Events

Intuitive Surgical Inc. – 5mm Curved Cannula for Single-Site Instruments for da Vinci Surgical Systems 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-2014-RN-00520-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2014-05-12
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00520-1
  • 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 (dta) in conjunction with the manufacturer, intuitive surgical inc., is issuing this recall for product correction for 5mm curved cannula for single-site instruments, to update the user manual. as indicated in the user manual addendum, cannula damage can include cracks in the tube or bowl/tube interface and tube wall anomalies etc and may result from incorrect placement of the cannulae. if cannula damage occurs during a procedure, then there is a possibility that the cannula or associated instrument may come in inadvertent contact with tissue and generate excessive forces on the patient body wall. this contact may cause tissue injury and require additional surgical and/or medical intervention.
  • 조치
    The “Single-Site Cannula Inspection and Use – Single-Site User Manual Addendum” will be hand delivered to the Nurse Unit Manager by your Product Specialist.

Device

Intuitive Surgical Inc. – 5mm Curved Cannula for Single-Site Instruments for da Vinci Surgical Sy...
  • 모델명 / 제조번호(시리얼번호)
    Intuitive Surgical Inc. – 5mm Curved Cannula for Single-Site Instruments for da Vinci Surgical SystemsAffected Products:INS-428061 5 X 300MM CURVED CANNULA ARM 1INS-428062 5 X 300MM CURVED CANNULA ARM 2INS-428071 5 X 250MM CURVED CANNULA ARM 1INS-428072 5 X 250MM CURVED CANNULA ARM 2ARTG Number: 97289
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd