Events

Procise EZ View with Integrated Cable(Electrosurgical electrode) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Smith & Nephew Surgical 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-2015-RN-00561-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-07-01
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00561-1
  • 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
    Smith & nephew surgical pty ltd. has initiated a recall of arthrocare corporation procise ez view with integrated cable wands, lot 1093290, due to a manufacturing inspection issue. affected lot of these devices have been released without meeting the dielectric specifications. in the event an affected wand is presented for surgery, the wand may develop a dielectric breakdown creating a small gap leading to arcing. this created arcing could lead to diminished ablation and coagulation performance and in rare instances a surgeon or patient burn. also, the decreased hemostasis resulting in injury or impairment could require additional medical intervention. to date there have been no reported adverse events related to this issue.
  • 조치
    Customers are advised to immediately discontinue use of the affected lot and take steps to quarantine the device(s). Smith & Nephew Surgical will arrange for affected products to be returned and suggest alternate products. This action has been closed-out on 05/12/2016.

Device

Procise EZ View with Integrated Cable(Electrosurgical electrode)
  • 모델명 / 제조번호(시리얼번호)
    Procise EZ View with Integrated Cable(Electrosurgical electrode)Product No.: EIC8875-01Lot Number: 1093290ARTG Number:221504
  • Manufacturer
    Smith & Nephew Surgical Pty Ltd

Manufacturer

Smith & Nephew Surgical Pty Ltd