Device Recall 8 mm Monopolar Curved Scissors 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Intuitive 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
    65216
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1442-2013
  • 사례 시작날짜
    2013-05-08
  • 사례 출판 날짜
    2013-05-31
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2014-05-01
  • 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
    System,surgical,computer controlled instrument - Product Code NAY
  • 원인
    Intuitive surgical has identified a potential for some units of the monopolar curved scissors version 09 and 10 instruments to develop very small cracks near the distal end. this may create a pathway for electrosurgical energy to leak to tissue and potentially cause thermal injury.
  • 조치
    Intuitive Surgical sent an Urgent Medical Device Recall letter dated May16, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were advised that they did not need to quarantine or return the affected device at that time. a Intuitive Surgical representative would contact them to arrange for replacement of the affected product once they became available. In the interim customers were instructed to follow the precautions and warnings outlined in Attachment A in the letter as well as the Instructions for Use. Customers were also asked to ensure all affected personnel were fully informed of the contents of the Recall Notification. The letter should be forwarded to other surgeons and/or managers within their facility. Customers were also asked to complete and return the attached Acknowledgement Form. For further questions customers were instructed to contact Customer Service: North and South America: 800-876-1310 Option 3 Japan: 0120-56-5635 or 003-5575-1362 Korea: 02-3271-3200 Europe, Middle East, Asia and Africa +800 0821 2020 or +41 21 821 2020 For questions regarding this recall call 408-523-2244.

Device

  • 모델명 / 제조번호(시리얼번호)
    Model Numbers 420179-09 and -10 and 400179-09 and -10.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution - USA (nationwide) Foreign Distribution to Argentina, Austria, Australia, Belgium, Brazil, Bulgaria, Canada, China, Chile, Czech Republic, Denmark, Finland, France, Germany, Cyprus- Greece, Egypt, Guadeloupe, Israel, Ireland, India, Indonesia, Italy, Japan, Kuwait, Lebanon, Malaysia, Mexico, Monaco, Netherlands, New Zealand, Norway, Pakistan, Philippines, Portugal, Poland, Qatar, Russia, Romania, Slovenia, South Korea, Spain, Sweden, Switzerland, Thailand, Taiwan, Turkey, United Kingdom, Saudi Arabia, Singapore, South Korea, and Venezuela.
  • 제품 설명
    8 mm Monopolar Curved Scissors (a.k.a. Hot Shears) || Manufactured and Distributed by: || Intuitive Surgical || Sunny vale, CA || The EndoWrist Monopolar Curved Scissors Instrument is a multiple-use endoscopic instrument utilizing a single use, tip cover accessory, to be used in conjunction with the Intuitive Surgical Endoscopic Instrument Control System.
  • Manufacturer

Manufacturer

  • 제조사 주소
    Intuitive Surgical, Inc., 1266 Kifer Rd Bldg 100, Sunnyvale CA 94086-5304
  • 제조사 모회사 (2017)
  • Source
    USFDA