Events

5mm and 8mm Harmonic ACE Instruments IFU (for use with 5mm Harmonic ACE instruments (PNs 400274 and 400275) 8mm Harmonic ACE instruments (PNs 420274 and 420275) and Harmonic ACE Curved Shears Disposable Insert (PN 400272) used with the da Vinci Standard, S, and Si 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-2015-RN-00114-1
  • 사례 위험등급
    Class III
  • 사례 시작날짜
    2015-02-17
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00114-1
  • 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 is informing the customers: intuitive surgical has found that the harmonic ace ifu used with the da vinci standard, s, and si surgical systems, contains incorrect instructions in regard to the proper use of the ininstrument release kit (irk) (or “emergency grip release allen wrench”). the harmonic ace ifu instructs the user to turn the irk counterclockwise. the correct instruction is to turn the irk clockwise.
  • 조치
    Device Technologies Australia (DTA) is requesting the users to discard the currentHarmonic ACE IFUs and to follow the instructions from the Instrument and Accessories User Manual, section 9.1. Introduction, paragraph General Precautions and Warnings; that is attached to the system.

Device

5mm and 8mm Harmonic ACE Instruments IFU (for use with 5mm Harmonic ACE instruments (PNs 400274 a...
  • 모델명 / 제조번호(시리얼번호)
    5mm and 8mm Harmonic ACE Instruments IFU (for use with 5mm Harmonic ACE instruments (PNs 400274 and 400275) 8mm Harmonic ACE instruments (PNs 420274 and 420275) and Harmonic ACE Curved Shears Disposable Insert (PN 400272) used with the da Vinci Standard, S, and Si Surgical Systems. Model Numbers: 550635-01; 550635-02; 550635-03; 550635-04
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd