Events

Covidien Emprint Percutaneous Antennas with Thermosphere Technology 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Medtronic Australasia 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-2017-RN-01018-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2017-08-10
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01018-1
  • 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
    Medtronic have received reports that the ceramic trocar tip of the emprint ablation antenna is disengaging from the needle shaft post-ablation. tip disengagement can result in the ceramic trocar tip remaining in the patient presenting a risk of latent migration and potential damage to adjacent tissue. four of the complaint reports indicate that the trocar tip was not retrieved.
  • 조치
    Medtronic is requesting customers: 1.Quarantine and discontinue use of the specified item codes and lots; 2.Immediately advise all surgeons/surgery personnel of this recall; 3. Check if their facility has distributed the affected products to other persons or facilities, if so, please promptly forward a copy of this letter to those recipients; 4. Email the completed Recall Response Form supplied with the customer letter to Medtronic's Regulatory Affairs Department at ANZ.Recalls@covidien.com or fax to 02 8904 8798. Please include a copy of the Recall Response Form with the returned units; and 5. Label the goods with the provided (ZRE#) for easy identification. Do not return goods without the corresponding ZRE# provided by Medtronic.

Device

Covidien Emprint Percutaneous Antennas with Thermosphere Technology
  • 모델명 / 제조번호(시리얼번호)
    Covidien Emprint Percutaneous Antennas with Thermosphere TechnologyEmprint Percutaneous Antenna with Thermosphere Technology, Short (15cm)Item Code: CA15L1Emprint Percutaneous Antenna with Thermosphere Technology, Standard (20cm)Item Code: CA20L1Emprint Percutaneous Antenna with Thermosphere Technology, Long (30cm)Item Code: CA30L1Lot Numbers beginning with S5L through S7GExpiration: November 2017 through July 2019ARTG Number: 178369
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • Manufacturer
    Medtronic Australasia Pty Ltd

Manufacturer

Medtronic Australasia Pty Ltd
  • 제조사 모회사 (2017)
    Medtronic plc
  • 제조사 의견
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    DHTGA