Events

Device Recall EndoWrist Stapler System User Manual Addendum and Wall Chart 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
    68814
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2171-2014
  • 사례 시작날짜
    2014-06-02
  • 사례 출판 날짜
    2014-08-08
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-08-08
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128783
  • 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
    Changes were made to the stapler endowrist stapler 45 system instruments and accessories user manual addendum (550986-03) and the endowrist stapler 45 wall chart (pn 551524-01) in which the ph range specification for the enzymatic cleaner used throughout the cleaning process was modified from ph-neutral to ph-neutral to mild alkaline (mild alkaline is defined as phd11). mild alkaline enzymatic.
  • 조치
    Intuitive Surgical representatives hand delivered corrected manuals to the two affected sites..

Device

Device Recall EndoWrist Stapler System User Manual Addendum and Wall Chart
  • 모델명 / 제조번호(시리얼번호)
    Model number 410298-05 and 410298-06
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Distribution to Florida and South Carolina
  • 제품 설명
    EndoWrist Stapler System User Manual Addendum and Wall Chart; || The EndoWrist Stapler 45 System and EndoWrist Stapler 45 Reloads are intended to be used with the da Vinci Si Surgical System (Model IS3000) for resection, transection and/or creation of anastomoses in General, Gynecologic and Urologic surgery. The device can be used with staple line or tissue buttressing material (natural or synthetic).
  • 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