Events

Device Recall Starion Instruments Real Hand ThermaSeal Thermal Ligating Shears 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Starion Instruments 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
    55750
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1972-2010
  • 사례 시작날짜
    2008-06-26
  • 사례 출판 날짜
    2010-07-09
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2010-10-27
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=91719
  • 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 & coagulation & accessories - Product Code GEI
  • 원인
    Due to an improper fixture revision, device may be missing a screw at the jaw assembly, resulting in jaw components falling off during use.
  • 조치
    The firm submitted an MDR but determined that there was no risk to health. E-mails were sent on June 26, 2008, to consignees, describing the product, the problem, and action to be taken by consignees. The consignees were ask to provide a list of all unused ThermaSeal devices and their locations, to return the products to Starion from the lots noted and to provide a copy of the attached letter to their sales force and customers if they choose. If you have any questions, please call (408) 522-5200 ext. 326 or (408) 350-9934.

Device

Device Recall Starion Instruments Real Hand ThermaSeal Thermal Ligating Shears
  • 모델명 / 제조번호(시리얼번호)
    Model Number N-10700, lot numbers 80419, 806009, 804037, 804035, 804036, 804019A.
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution.
  • 제품 설명
    Starion Instruments Real Hand ThermaSeal Thermal Ligating Shears, electrosurgical cutting and coagulation device and accessories, manufactured by Starion Instruments, Sunnyvale, CA || Intended use: Medical Device used for cutting and cauterization of soft tissue during surgery, and of natural or synthetic, non-metallic sutures during surgery.
  • Manufacturer
    Starion Instruments

Manufacturer

Starion Instruments
  • 제조사 주소
    Starion Instruments, 775 Palomar Ave, Sunnyvale CA 94085-2915
  • 제조사 모회사 (2017)
    HOYA Corp.
  • Source
    USFDA