Events

Device Recall Starion Instruments 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
    55043
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2239-2010
  • 사례 시작날짜
    2010-03-09
  • 사례 출판 날짜
    2010-08-19
  • 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=89744
  • 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/cauterization and accessories - Product Code GEI
  • 원인
    The starion instruments thermal ligating shears (stls) 35c and the starion thermal ligating shears (stls) 23c may turn on and remain on without the finger button being depressed. the devices may also work intermittently, incorrectly indicating the device is 'on".
  • 조치
    Starion distributed a "STLS Device Recall - Important Medical Device Information" letter dated March 9, 2010 to consignees. The letter identified the affected model and lot numbers. Consignees were asked to complete a inventory status form and fax to Starion. the letter included a shipping labe with a pre-assigned return authorization number. Starion will ship replacement after receipt of the inventory status form and returned product..

Device

Device Recall Starion Instruments Thermal Ligating Shears
  • 모델명 / 제조번호(시리얼번호)
    STLS 23C: Model numbers 102-137D, Lot Numbers: 905029, 907007, 910016, 908022  STLS 35C: Model 102-138D, Lot Numbers: 907004 and 907008
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution: USA states of CA, OH, MI, KS and MO and countries of Italy, China, Kuwait, and Germany.
  • 제품 설명
    The Starion Instruments Thermal Ligating Shears 35C Model 102-138D and 23C Model numbers 102-137D allow the surgeon to position the distal jaws of the instrument around the region of tissue to be cut/cauterized. The surgeon squeezes the handle and depresses the switch, heating elements activates in the jaws. The heat is conducted to the tissue between the jaws to provide cutting/cauterization. For the simultaneous cutting and cauterization of soft tissue during surgery. 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