Events

Neuray® Neurosurgical Patties and Strips and Merocel® Neurosurgical Patties and Packing 에 대한 현장 안전성 서한

Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI)에 따르면, 해당 현장 안전성 서한 는 Slovenia 에서 Medtronic 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

현장 안전성 서한은 의료기기 제조사 또는 제조사 대리인이 시중에 유통되고 있는 자사 의료기기 제품에 대하여 취할 수 있는 조치를 알리는 소통방식입니다. 주요 대상층은 보건의료업계 종사자와 의료기기 사용자들입니다. 여기에는 회수(recall) 조치와 경고도 포함될 수 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Field Safety Notice
  • 사례 국가
    Slovenia
  • 사례 출처
    AMPMDRS
  • 비고 / 경고
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
  • 데이터 추가 비고
  • 원인
    The purpose of this letter is to advise you that medtronic is updating the instructions for use (“ifu”) for the neuray® and merocel® neurosurgical patties. the updated instructions for use provided include precautions that will help reduce the potential for clinical consequences when neurosurgical patties, which are designed to be x-ray detectable or radiopaque to assist with post-procedural removal in the event of a missing device, are not visible during x-ray imaging. therefore, medtronic is including the following precautions: • “count all devices before and after the procedure prior to surgical closure. in the event a device cannot be located; an x-ray can be used to locate the devices. only the radiopaque markers are visible on imaging. the size and position of the radiopaque markers may impact their visibility." • "it is recommended that at least three views, using the optimal parameters for the imaging (x-ray) equipment, at a variety of angles (e.G., 45 degrees, 22.5 degrees, and 0 degree angles) for anterior and posterior, or the appropriate plane, be taken and examined for a missing device. if there are concerns regarding visualization, consult with your local imaging expert to establish the optimal radiographic parameters (e.G., kvp, mas) for visualization with the imaging equipment.” • “avoid cutting the patties because fragments without x-ray detectable material may enter the surgical site. fragments left in the surgical site may result in an unintended adverse reaction.” • “the locator string will not be visible by x-ray as it is not radiopaque. avoid using the locator strings to remove the patties from the surgical site to prevent detachment.” .

Device

Neuray® Neurosurgical Patties and Strips and Merocel® Neurosurgical Patties and Packing
  • 모델명 / 제조번호(시리얼번호)
    8003097 PACKING 8003097 NEURAY 200PK 7X38MM 8003098 PACKING 8003098 NEURAY 200PK 7X76MM 8003099 PACKING 8003099 NEURAY 200PK 7X7MM 8004000 PACKING 8004000 NEURAY 200PK 13X13MM 8004001 PACKING 8004001 NEURAY 200PK 19X19MM 8004002 PACKING 8004002 NEURAY 200PK 13X25MM 8004003 PACKING 8004003 NEURAY 200PK 25X25MM 8004004 PACKING 8004004 NEURAY 200PK 13X38MM 8004005 PACKING 8004005 NEURAY 200PK 38X38MM 8004006 PACKING 8004006 NEURAY 200PK 13X51MM 8004007 PACKING 8004007 NEURAY 200PK 13X76MM 8004008 PACKING 8004008 NEURAY 200PK 25X76MM 8004009 PACKING 8004009 NEURAY 200PK 76X76MM 8004050 PACKING 8004050 NEURAY 200PK 7X152MM 8004051 PACKING 8004051 NEURAY 200PK 13X152MM 8004052 PACKING 8004052 NEURAY 200PK 19X152MM 8004053 PACKING 8004053 NEURAY 200PK 25X152MM 8004054 PACKING 8004054 NEURAY 200PK 38X152M 8004055 PACKING 8004055 NEURAY 200PK 50X152MM 8004056 PACKING 8004056 NEURAY 200PK 76X152MM 8004057 PACKING 8004057 NEURAY 200PK 89X152MM Merocel Neurosurgical Patties and Packing 300501 SPONGE 300501 MEROCEL 100PK 1.3 X 1.3CM 300503 SPONGE 300503 MEROCEL 100PK 1.3 X 2.5CM 300505 SPONGE 300505 MEROCEL 100PK 1.3 X 5.1CM 300506 SPONGE 300506 MEROCEL 100PK 1.3 X 7.6CM 300507 SPONGE 300507 MEROCEL 100PK 2.5 X 2.5CM 300509 SPONGE 300509 MEROCEL 100PK 2.5 X 5.1CM 300510 SPONGE 300510 MEROCEL 100PK 2.5 X 7.6CM 300514 SPONGE 300514 MEROCEL 100PK 8.3 X 8.3CM 300515 SPONGE 300515 MEROCEL 100PK .7 X 7.6CM 400611 PACKING 400611 10PK NEUROSURGICAL
  • Manufacturer
    Medtronic

Manufacturer

Medtronic
  • 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
    AMPMDRS