Events

ROSA Brain 3.0.0 Robotic Surgical Assistant 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-2017-RN-00404-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2017-03-24
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00404-1
  • 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
    Investigation revealed that a computer file parameter that is linked to the robot arm calibration has been modified by the robot arm supplier without notification to the manufacturer. as a result, once the robot arm is on a trajectory, if the system reboots or shuts down (voluntarily or due to an error) without the robot arm returning to a parking position, the device’s applicative accuracy may decrease to a level below the applicable specification. in the event that the inaccurate tool positioning of the instruments by the rosa devices is not detected by the user, it could ultimately lead to ineffective treatment, serious injury or death of the patient. to date, no complaint reports, which could be linked to the above issue in normal conditions of use, have been recorded.
  • 조치
    As an interim measure, Surgicom is requesting users to follow the instructions as detailed in the recall notification letter. This action has been closed-out on 15/03/2018.

Device

ROSA Brain 3.0.0 Robotic Surgical Assistant
  • 모델명 / 제조번호(시리얼번호)
    ROSA Brain 3.0.0 Robotic Surgical AssistantSerial Number: BR15002ARTG Number: 235379
  • Manufacturer
    Surgicom Pty Ltd

Manufacturer

Surgicom Pty Ltd
  • Source
    DHTGA