Events

Percuvance Percutaneous Surgical System 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Teleflex Medical Australia 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-01400-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2017-11-13
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01400-1
  • 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
    Teleflex has identified that the percuvance percutanous surgical system jaws of the tool tip may break, causing a fragment of the tool tip to fall off during use. if breakage occurs during a procedure, additional operating time or enlargement of the incision may be required to retrieve the fragment from the patient. if the fragment cannot be retrieved easily, additional complications could occur. teleflex has not received any reports of patient injuries or deaths relating to the recalled products.
  • 조치
    Teleflex is advising users to quarantine any remaining units of the affected stock for credit.

Device

Percuvance Percutaneous Surgical System
  • 모델명 / 제조번호(시리얼번호)
    Percuvance Percutaneous Surgical SystemProduct Code: PCVJG5, PCVMD5, PCVHCA5, PVCGG5, PCVSC5Multiple lot Numbers affectedARTG number 126369 (Teleflex Medical Australia Pty Ltd - Applier, surgical, clip, haemostatic, single use)
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • Manufacturer
    Teleflex Medical Australia Pty Ltd

Manufacturer

Teleflex Medical Australia Pty Ltd