Events

Device Recall Starion Instruments TLS3 35C 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
    55721
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1969-2010
  • 사례 시작날짜
    2008-02-06
  • 사례 출판 날짜
    2010-07-08
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2010-11-27
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=91718
  • 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
    Some jaws exhibited lack of ductility and could break if overloaded or used improperly by placing too much tissue in the bottom of the "v" of the jaw.
  • 조치
    The firm called domestic consignees but no letter was sent to domestic cosignees and a notification letter was sent to international consignees. The firm called domestic consignees and sent a notification letter to international consignees. No records were kept of phone calls and a copy of the letter sent to international consignees was not obtained

Device

Device Recall Starion Instruments TLS3 35C Thermal Ligating Shears
  • 모델명 / 제조번호(시리얼번호)
    Model number 132-136D, lot numbers 708027 and 710008, expiration dates 09/21/12 and 10/19/12
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution
  • 제품 설명
    Starion Instruments TLS3 35C Thermal Ligating Shears, Electrosurgical cutting and coagulation device and accessories, manufactured by Starion Instruments Corp, Sunnyvale, CA. || Intended use: medical device for use in cutting and cauterization of soft tissue during surgery, as well as cutting 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