Events

Multiple AxiEM ENT Suction Instruments Straight Suction EM, ENTCurved Suction 70 EM, Short Curved Suction 90, EM Suction Small Straight AxiEM ENT 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-00861-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2017-07-12
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00861-1
  • 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 has become aware that the specific lots of axiem ent suction instruments are not able to pass instrument verification. instrument verification is a step in the software which is performed prior to the use of each instrument. this verification step confirms device tracking functionality and prevents use of the device if a passing verification is not achieved. the impacted devices were made with a particular stainless steel stock material that exhibits magnetic characteristics (magnetic permeability), causing interference with electromagnetic (em) tracking capability of the stealthstation.If this issue presents during surgery, it may result in surgery being extended to troubleshoot the issue, discontinuation of navigation, or aborting surgery if alternative instruments are not available to proceed. to date, there have been no reports of patient injury.
  • 조치
    Medtronic is requesting customers examine their inventory and if any of the affected products listed in the customer letter are found, immediately cease use and quarantine them for return to Medtronic. Alternatively, each local Medtronic Sales Representative will perform this step. If the product has been removed from its original packaging, the part number and lot number can be found printed directly on the device as shown in the pictures given in the customer letter.

Device

Multiple AxiEM ENT Suction Instruments Straight Suction EM, ENTCurved Suction 70 EM, Short Curved...
  • 모델명 / 제조번호(시리얼번호)
    Multiple AxiEM ENT Suction InstrumentsStraight Suction EM, ENTCurved Suction 70 EM, Short Curved Suction 90, EM Suction Small Straight AxiEM ENTMultiple Part and Lot NumbersThese instruments may also be included in the following kits:ENT Instrument SetFusion ENT Instrument KitENT AxiEM Instrument SetENT Prgm Add Fusion Nav AxiEMARTG Numbers: 129428, 125074 & 120114
  • 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