Events

Medtronic Midas Rex Sagittal Saws (used with the Medtronic Integrated Power Console (IPC) System) 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-2016-RN-00795-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-06-15
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00795-1
  • 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
    This action is being taken to mitigate the risk of injury associated with the potential for leakage of fluid into the motor through the rocker housing seal. the seal is intended to prevent ingress of fluid into the sagittal microsaws during use and decontamination. although there have been no reports of fluid leakage occurring in the field, engineering testing of the seal identified the potential for leakage to occur. in assessing the risk of this potential failure, testing was conducted that indicated the gravity displacement sterilisation cycle which is included in the ipc user manual may not be adequate to ensure sterility of internal motor components if fluid ingress occurs beyond the rocker housing seal. in the event that fluid leaks into the motor through the rocker housing seal, and gravity displacement sterilisation method is used, if fluid leaks from the motor during use and this fluid contacts the patient surgical site, there is a potential for infection to occur.
  • 조치
    Customers are advised to check their inventory for the affected products. A Medtronic Representative will be in touch with customers to organise the return of this product. This action has been closed-out on 17/02/2017.

Device

Medtronic Midas Rex Sagittal Saws (used with the Medtronic Integrated Power Console (IPC) System)
  • 모델명 / 제조번호(시리얼번호)
    Medtronic Midas Rex Sagittal Saws (used with the Medtronic Integrated Power Console (IPC) System)Saw SagittalItem Number: ES300Saw Sagittal, RefurbishedItem Number: ES300-RSaw Sagittal, FingerItem Number: ES310Saw Sagittal, Finger, RefurbishedItem Number: ES310-RAll Serial Numbers affectedARTG Number: 200336
  • 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