Events

da Vinci Si" Surgical System 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
    69283
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0074-2015
  • 사례 시작날짜
    2014-09-18
  • 사례 출판 날짜
    2014-10-16
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2015-03-03
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=130164
  • 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 is issuing an urgent product notice to all users of the endowrist stapler 45 to discontinue use due to reports of inability to remove the stapler from tissue.
  • 조치
    Intuitive Surgical sent an Urgent Product Notice letter dated September 19, 2014 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to: -Immediately stop using the EndoWrist Stapler 45 instrument. -Quarantine the EndoWrist Stapler 45 instruments within your hospital. Keep the instruments quarantined until Intuitive Surgical sends you a subsequent communication with instructions regarding the quarantined product. -Ensure all affected personnel are fully informed of this notice. Forward this notice to your Risk Manager, OR Director, Purchasing Manager, Biomedical Engineering staff, and members of your medical staff who perform da Vinci Si surgery procedures using the EndoWrist Stapler 45 instrument. -Please retain a copy of this notice for your records with your da Vinci Si User Manual. If ¿you ¿need ¿further ¿information ¿or ¿support ¿concerning ¿this ¿Product ¿Notice, ¿please contact your Clinical Sales Representative or Intuitive Surgical Customer Service at 800-876-1310 Option ¿3 ¿(6 ¿am ¿to ¿5 ¿pm ¿PST). ¿

Device

da Vinci Si" Surgical System
  • 모델명 / 제조번호(시리얼번호)
    EndoWrist Stapler 45 instrument, Model Number: IS3000 Part Number: PN 410298-06, -07, -08, -09 All Lots.
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US Nationwide Distribution.
  • 제품 설명
    EndoWrist Stapler 45 instrument for the da Vinci Si System || Model Number: IS3000 || Product Usage: || For use with da Vinci Si System. The Intuitive Surgical Endoscopic Instrument Control System is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, ultrasonic shears, forceps/pick-ups, needle holders, endoscopic retractors, stabilizers, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, transoral otolaryngology surgical procedures restricted to benign and malignant tumors classified as TI and T2, general thoracoscopic surgical procedures, and thoracoscopically assisted cardiotomy procedures. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. The system is indicated for adult and pediatric use (except for transoral otolaryngology surgical procedures). It is intended to be used by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.
  • Manufacturer
    Intuitive Surgical, Inc.

Manufacturer

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