Events

Cooper Surgical RUMI Arch 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Cooper Surgical, Inc. 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
    63681
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0439-2013
  • 사례 시작날짜
    2012-10-31
  • 사례 출판 날짜
    2012-11-26
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-03-04
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114522
  • 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
    Cannula, manipulator/injector, uterine - Product Code LKF
  • 원인
    Excessive pressure exerted on the uterine tip when attached to the arch may, under certain circumstances, cause the internal steel rod of the tip to protrude through the cleaning hole on the shaft of the handle.
  • 조치
    CooperSurgical issued notification on October 31, 2012, to all affected customers Fed X . The notification identified the product, the problem, and the action to be taken by the customer. Customers were instructed to return units for replacement. Customers with questions should contact Customer Serivce at 1-203-601-9818 or 800-243-2974. Customers were asked to fill out the attached Replacement of Recalled Product Form and fax it to 1-800-262-0105. For questions regarding this recall call 203-601-9818.

Device

Cooper Surgical RUMI Arch
  • 모델명 / 제조번호(시리얼번호)
    All serial numbers
  • 의료기기 분류등급
    Obstetrical and Gynecological Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA (nationwide) and Internationally to Australia, Belgium, Canada, Czech Republic, Germany, Italy, Spain, France, United Kingdom, Japan, New Zealand, South Korea, Saudi Arabia, Sweden, Singapore, Slovenia, and Taiwan.
  • 제품 설명
    Cooper Surgical RUMI Arch, Reusable Uterine Manipulator Handle || Ref: UMH700 || The intended use of the RUMI Arch is in an operative endoscopy (laparoscopy) where a uterus is present and where positioning of the uterus, fallopian tubes and ovaries is desirable. These types of surgeries include laparoscopic tubal ligation, and/or operative laparoscopy
  • Manufacturer
    Cooper Surgical, Inc.

Manufacturer

Cooper Surgical, Inc.
  • 제조사 주소
    Cooper Surgical, Inc., 95 Corporate Dr, Trumbull CT 06611-1350
  • 제조사 모회사 (2017)
    The Cooper Companies, Inc.
  • Source
    USFDA