Events

DA VINCI Endoscopic Instrument Control System 의 안전성 경고

National Institute of Drugs and Food Surveillance (INVIMA)에 따르면, 해당 안전성 경고 는 Colombia 에서 manufacturer #121 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

안전성 경고는 의료기기 제품과 관련된 중요한 정보와 권고사항을 담고 있습니다. 물론 안전성 경고가 배포되었다고 해서 해당 제품이 무조건 안전하지 않은 제품이라는 것은 아닙니다. 보건의료업계 종사자와 의료기기 사용자들에게 배포되는 안전성 경고에는 회수(recall)도 포함될 수 있습니다. 제조사가 안전성 경고를 작성하기도 하지만, 보건당국에서 작성하는 경우도 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Safety alert
  • 사례 ID
    I1503-136
  • 사례 연번
    2009DM-0003498
  • 날짜
    2017-03-19
  • 사례 국가
    Colombia
  • 사례 출처
    INVIMA
  • 사례 출처 URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=96
  • 비고 / 경고
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 Colombia.
  • 데이터 추가 비고

Device

DA VINCI Endoscopic Instrument Control System
  • 모델명 / 제조번호(시리얼번호)
    references 420022-02, 420256- 01, 420258-01, 420026-01, 420279-03, 420273-02, 420290- || 03, 420291-03, 420281-02, 420015-03, 400027-04, 400016- || 04 and 400015-03
  • 제품 설명
    The purpose of the INTUITIVE SURGICAL endoscopic instrument control system is to help accurately control INTUITIVE endoscopic instruments, such as rigid endoscopes, endoscopic dissectors and incisors, scissors, scalpels, forceps / clamps, needle handling tools, endoscopic retractors, stabilizers, accessories for electrocautery and for endoscopic manipulation, for example to hold them, cut them, perform a blunt or incisal excision, bring them closer, ligate them, electrocauterize them and suture them during general laparoscopic surgical procedures, general non-cardiovascular thoracoscopic surgical procedures and thoracoscopic assisted cardiotomy interventions. The system can also be used with adjoining mediastinotomy to perform coronary anastomosis during cardiac revascularization. The system is indicated for use in adults and pediatrics. It is designed to be used by qualified physicians in surgical environments, using the representative and specific procedures described in the instructions for use. INTUITIVE SURGICAL's endoscopic instrument control system has been successfully used, among others, in the following procedures; • radical prostatectomy, pyeloplasty, cystectomy, nephrotomy, urethral reimplantation • cholecystectomy, Nissen fundoplication, Heller's myotomy, gastric deviation, donor nephrotomy, adrenalectomy, splenectomy, and intestinal resection. • hysterectomy, myomectomy, sacrocopopaxy • mobilization of the internal mammary artery, ablation of cardiac tissue • repair of the mitral valve, endoscopic closure of atrial septal defects, • breast anastomosis of the left anterior descending coronary artery for cardiac revascularization with adjunctive mediastinotomy -representative pediatric: the control system of endoscopic instruments of INTUITIVE SURGICAL has been
  • Manufacturer
    manufacturer #121

Manufacturer

manufacturer #121
  • 제조사 모회사 (2017)
    Abbott Laboratories
  • 제조사 의견
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    NIDFSINVIMA