Events

Device Recall GYRUS ACMI PKS PlasmaSEAL Open Forceps 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Gyrus Medical, Inc. 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
    35477
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1175-06
  • 사례 시작날짜
    2006-05-15
  • 사례 출판 날짜
    2006-06-27
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2007-01-12
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=46199
  • 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
    Gyrus acmi has identified a product issue wherein their plasmaseal open forceps, models 2103pk and 917015pk, may not deliver adequate hemostasis during use. although gyrus acmi has had no reports of serious injury to patient, testing indicated that the possibility exists.
  • 조치
    US accounts were initially contacted by phone beginning 05/15/2006 and then sent a follow-up letter sent 05/31/2006. Customers were told of the issue, instructed to discontinue use of the product, told to remove all 2103PK and 917015PK devices from shelves and to quarantine product until they receive a letter with instructions to return the affected devices to Gyrus ACMI.

Device

Device Recall GYRUS ACMI PKS PlasmaSEAL Open Forceps
  • 모델명 / 제조번호(시리얼번호)
    Catalog No. 2103PK and 917015PK all production codes
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide, Australia, Canada, Netherlands. (AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, PA, RI, SC, TN, TX, VA, WA, WI, WV).
  • 제품 설명
    GYRUS ACMI PKS PlasmaSEAL Open Forceps, model 2103PK and 917015PK. Sterile EO. The device is intended to be used with the PlasmaKinetic electrosurgical generator, software version 1.93 or greater or the PlasmaKinetic with SuperPulse electrosurgical generator, software version 2.19A or greater or the G400 electrosurgical generator. Made in USA Gyrus ACMI, Gyrus Medical, Inc., 6655 Wedgwood Road, Suite 160, Maple Grove, MN 55311-3602.
  • Manufacturer
    Gyrus Medical, Inc.

Manufacturer

Gyrus Medical, Inc.
  • 제조사 주소
    Gyrus Medical, Inc., 6655 Wedgewood Road, Suite 105, Maple Grove MN 55311
  • Source
    USFDA