Device Recall Neptune Waste Management System 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Stryker Instruments Div. of Stryker Corporation 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
    61747
  • 사례 위험등급
    Class 1
  • 사례 연번
    Z-2063-2012
  • 사례 시작날짜
    2012-06-08
  • 사례 출판 날짜
    2012-08-15
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2016-08-23
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 비고 / 경고
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • 데이터 추가 비고
    Apparatus, exhaust, surgical - Product Code FYD
  • 원인
    Stryker has received two reports of serious injury as a result of tissue damage associated with the use of the neptune 2, including an event in which one customer connected the neptune 2 system to a passive chest drainage tube post operatively, resulting in a fatality. the current ifu did not specifically warn against connecting all neptune waste management devices, which is a high vacuum/high flow device, to a passive drainage tube. june 12, 2012, customers were instructed to review the revised ifu, distribute to affected departments, and educate users of the neptune on this warning. warning labels, which are pending distribution, are required on all neptune devices. further investigation found the neptune 1 silver, neptune 2 ultra (120v) and neptune 2 ultra (230v) lacked fda 510(k) clearance and therefore are not legally marketed without determination of their safety and effectiveness. fda advises neptune 1 silver, neptune 2 ultra (120v) and neptune 2 ultra (230v) not be used. however, customers who do not have an alternative device to use should weigh the risks and benefits associated with continued use of these devices. if customers choose to continue use of the neptune silver, neptune 2 ultra (120v) or neptune 2 (230v), they must complete a certificate of medical necessity and return it to stryker by october 12, 2012.
  • 조치
    On June 5, 2012, Stryker notified customers that it was recalling the IFUs for the above products. The current IFU did not specifically warn against connecting the Neptune Rover, which is a high vacuum/high flow device, to a passive drainage tube. Customers were instructed to review the revised IFU, distribute to affected departments, and educate users of the Neptune on this warning. Customers must confirm with Stryker via business reply form that they have completed these actions. Customers who have the Neptune 1 Gold, Neptune 1 Gold International or Neptune 2 Bronze will receive a follow up mailing containing warning labels for the device and instructions detailing how to apply them. Customers may continue to use the Neptune 1 Gold, Neptune 1 Gold International, and the Neptune 1 Bronze without any further actions. On September 18, 2012, Stryker notified customers via letter delivered by FedEx overnight delivery that it is expanding the recall on the Neptune 1 Silver, Neptune 2 Ultra (120V) and Neptune 2 Ultra (230V) because FDA has also advised Stryker that these devices require, but do not currently have, 510(k) clearance. FDA is therefore unable to determine whether these devices are as safe and effective as their legally marketed predicate, the Neptune 1 (Gold) Waste Management System (510(k) K012992). As such, Stryker has ceased distribution of the Neptune Silver, Neptune 2 Ultra (120V) and Neptune 2 Ultra (230V) devices until FDA clears these devices. At this time, FDA does not consider the Neptune Silver, the Neptune 2 Ultra (120V) or the Neptune 2 Ultra (230V) to be legally marketed devices because their safety and effectiveness have not yet been determined. As such, FDA advises that the devices not be used. However, customers who do not have an alternative device to use should weigh the risks and benefits associated with continued use of these devices. If customers choose to continue use of the Neptune Silver, Neptune 2 Ultra (120V) or Nept

Device

  • 모델명 / 제조번호(시리얼번호)
    Part : 0700-007-000, all lot numbers IFU Part number 0700-007-720
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- USA (nationwide) and country of: Canada. .
  • 제품 설명
    Stryker Neptune Bronze Rover, Part 0700-007-000 || Neptune Bronze Rover Waste Management System Instructions For Use. || Intended for use in the surgical environment or physician's office to collect and dispose of surgical fluid waste.
  • Manufacturer

Manufacturer

  • 제조사 주소
    Stryker Instruments Div. of Stryker Corporation, 4100 E Milham Ave, Portage MI 49002-9704
  • 제조사 모회사 (2017)
  • Source
    USFDA