Events

Device Recall Spyscope DS Access and Delivery Catheter 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Boston Scientific 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
    79529
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1133-2018
  • 사례 시작날짜
    2017-12-20
  • 사례 상황
    Open, Classified
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162595
  • 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
    Choledochoscope and accessories, flexible/rigid - Product Code FBN
  • 원인
    Certain lots of devices may have the working channel sleeve protruding from the camera cap which may result in injuries from minor tissue damage to significant bleeding.
  • 조치
    The notification letter requests the consignee to identify and return the affected product along with the response form. Distributors are asked to share the recall information to the customer level. 12/20/2017 by mail.

Device

Device Recall Spyscope DS Access and Delivery Catheter
  • 모델명 / 제조번호(시리얼번호)
    21071349 21186199 21264281 21338493 21072506 21186874 21264826 21339969 21097205 21189216 21268628 21346857 21099913 21192332 21269880 21348369 21101809 21194784 21275009 21348655 21104860 21196427 21279183 21351508 21106212 21196815 21280166 21354138 21111667 21197475 21282419 21355128 21112353 21198355 21284302 21356067 21120166 21201164 21285174 21359495 21121467 21203598 21285708 21360857 21125598 21204762 21287283 21361914 21129863 21207916 21291325 21366469 21134585 21210287 21291903 21368941 21136699 21212151 21295990 21372468 21139834 21215249 21301969 21373463 21143014 21216252 21302617 21373946 21 150144 21218379 21305351 21377827 21150932 21220903 21307321 21380698 21156170 21221247 21308963 21381638 21159396 21226282 21310860 21385327 211 60496 21227147 21311361 21387164 21163684 21233949 21313025 21387745 2 1164861 21235402 21313392 21391319 21165772 21237929 21315518 21393249 211 68729 21240546 21316968 21393900 21169977 21241587 21317017 21395015 21170814 21245984 21322828 21395016 21174026 21246770 21324197 21401047 211 75845 21249893 21324851 21401048 211 76842 21251968 21329021 21401049 21180343 21253001 21329708 21413940 21181253 21254244 21332229 21414750 21181677 21257214 21334848 21420240 21186002 21260915 21335787
  • 의료기기 분류등급
    Gastroenterology-Urology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution US nationwide, Austria, Belarus, Belguim, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Hungary, Ireland, Israel, Italy, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Spain, Sweden, Switzerland, Bahrain, China, Hong Kong, India, Malaysia, Pakistan, Qatar, Saudi Arabia, Singapore, South Africa, South Korea, Thailand, Tunisia, Turkey, Vietnam, Brazil, Canada, Cost Rica, Ecuador, Guatemala, Mexico, Peru
  • 제품 설명
    SpyScope DS Access and Delivery diagnostic biliary catheter, M00546600
  • Manufacturer
    Boston Scientific Corporation

Manufacturer

Boston Scientific Corporation
  • 제조사 주소
    Boston Scientific Corporation, 100 Boston Scientific Way, Marlborough MA 01752-1234
  • 제조사 모회사 (2017)
    Boston Scientific
  • 제조사 의견
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    USFDA