Events

da Vinci Xi instrument & accessoriesAffected instruments:0 deg, 8mm Endoscope, IS4000 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-2015-RN-01265-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-12-24
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01265-1
  • 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 intuitive surgical has identified specific configurations in which monopolar energy has the potential to be transmitted from the da vinci xi endoscope shaft to tissue it is contacting. although there have been no reported complaints related to this issue, these configurations have the potential to result in unintended thermal injury.
  • 조치
    The sponsor is advising users to follow the instructions given in the customer letter to mitigate the risk of thermal injury, specifically: • Monopolar energy should not be used when the da Vinci Xi 8 mm endoscope is introduced via the 12 mm da Vinci cannula. This is the case whether or not the da Vinci 12 mm to 8 mm cannula reducer is used. • Never insert a da Vinci Xi cannula into another cannula placed in the patient’s body wall (i.e. double cannulation). • Use caution when using monopolar energy during da Vinci Xi procedures in which contact between the endoscope cannula and the body wall is not assured. This action has been closed-out on 28/02/2018.

Device

da Vinci Xi instrument & accessoriesAffected instruments:0 deg, 8mm Endoscope, IS4000
  • 모델명 / 제조번호(시리얼번호)
    da Vinci Xi instrument & accessoriesAffected instruments:0 deg, 8mm Endoscope, IS4000Part numbers: 470026-34, 470026-40, 470026-41 DT ordering code: INS-470026 30 deg, 8mm Endoscope, IS4000 Part numbers: 470027-34, 470027-40, 470027-41 DT ordering code: INS-470027 Affected User Manual:Part number: 551706Language: English ARTG: 99242
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd