Events

Rosa One 3.1(Surgical robot for spine and brain surgeries) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Surgicom Pty Ltd 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
    RC-2016-RN-01658-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2017-06-09
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01658-1
  • 비고 / 경고
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • 데이터 추가 비고
  • 원인
    Two software issues have been identified with the rosa one 3.1.1. specific to spinal surgery application - a product complaint was received by the manufacturer that indicated a risk for robot collision. when driving the robot arm in a surgical procedure, the robot arm comes too close to the robot stand, which leads to the possiblity of colliding with the stand. this issue was further observed during multiple attempts to enable the function "clear the arm (cooperative mode)". the rosanna spine software (version 3.1.0.1225) was identified as non-conforming to the release design.2. specific to brain surgery application - part of the rosa one 3.1 mario software (robot arm software) related to safety in the "cooperative mode" is currently deactivated. the risk of unwanted robot motion with an instrument into the anatomy is mitigated by this software measure.To date, their have been no injuries reported due to these issues.
  • 조치
    Software corrections for the Rosa One 3.1 will be performed on site. The Rosanna Spine software correction has occured. Until the Mario software for the brain application is modifed, usage of the device is to be limited to the spine application only. This action has been closed-out on 09/06/2017.

Device

Rosa One 3.1(Surgical robot for spine and brain surgeries)
  • 모델명 / 제조번호(시리얼번호)
    Rosa One 3.1(Surgical robot for spine and brain surgeries)Item Number: ROSA00208Serial Number: BS16001ARTG Number: 278903
  • Manufacturer
    Surgicom Pty Ltd

Manufacturer

Surgicom Pty Ltd
  • Source
    DHTGA