Events

Device Recall MACROLYTE 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 ConMed Corporation 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
    68193
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1719-2014
  • 사례 시작날짜
    2014-05-08
  • 사례 출판 날짜
    2014-06-04
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-04-11
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=127122
  • 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
    Electrosurgical, cutting and coagulation and accessories - Product Code GEI
  • 원인
    Conmed corporation has received complaints regarding sparking, no output and burning at the cord set connection. the complaints have been confirmed by conmed.
  • 조치
    ConMed sent an Urgent Medical Device Recall letter dated May 8, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Corrective Action: All returned devices will be received into the facility and the lot number and quantity recorded on to an electronic spreadsheet. The returned product will then be stored in a secure quarantined area. At this time, management has not determined as to how the devices will be dispositioned. A protocol(s) will be written to address the destruction of the returned devices. This will be submitted to NYK-DO for approval prior to any action being taken with the returned devices. CAPA 153136 was opened. Fixtures were revised to allow for placement of the foil/gel substrate from the bottom of the foam. This is to maintain consistent dimensions on the product and not allow for float/movement of the substrate from being offset. For further questions please call (315) 624-3024 or fax to (315) 624-3030.

Device

Device Recall MACROLYTE
  • 모델명 / 제조번호(시리얼번호)
    Beginning Lot Code 1204275; Ending Lot Code 1401075 (Lot code indicates the date of manufacture = yymmdds, where s is the shift).
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA (nationwide) and the countries of Australia, Belgium, Brazil, Canada, Ecuador, El Salvador, Finland, France, Great Britain, Honduras, India, Indonesia, Israel, Italy, Japan, Latvia, Lebanon, Malaysia, Mexico, Panama, Philippines, Portugal, Saudi Arabia, South Africa, Spain, Thailand, Trinidad, United Arab Emirates and Uruguay.
  • 제품 설명
    MACROLYTE Premie Dispersive Electrode, REF 440-2400, CONMED CORPORATION. The device is applied to the patient during electrosurgical procedures to provide a path for RF current to leave the patient and return to the generator.
  • Manufacturer
    ConMed Corporation

Manufacturer

ConMed Corporation
  • 제조사 주소
    ConMed Corporation, 525 French Rd, Utica NY 13502-5945
  • 제조사 모회사 (2017)
    CONMED Corp.
  • Source
    USFDA