Events

Device Recall EVac 70 XTRA with Integrated Cable and PROcise EZ View with Integrated Cable 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 ArthroCare 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
    71468
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2105-2015
  • 사례 시작날짜
    2015-06-02
  • 사례 출판 날짜
    2015-07-18
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2016-06-27
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=137892
  • 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
    Wands inspected with the adaptor fixture were released to the field not meeting the dielectric (hipot) specifications.
  • 조치
    Smith&Nephew; sent an Urgent Notification letter dated June 10, 2015 via mail/courier service with delivery tracking/confirmation to affected customers. A response form is included in the notification letter. A follow up letter will be sent to non-responding consignees. Customers were instructed to complete the acknowledgement form and return via fax or email.

Device

Device Recall EVac 70 XTRA with Integrated Cable and PROcise EZ View with Integrated Cable
  • 모델명 / 제조번호(시리얼번호)
    Lot numbers 1093290 and 1091254
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Germany, Spain, United Kingdom, Ireland, India, Italy and Singapore.
  • 제품 설명
    EVac 70 XTRA with Integrated Cable and PROcise EZ View with Integrated Cable || Product Usage: || PLASMA WAND devices are indicated for ablation, resection, and coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (ENT) surgery including: adenoidectomy, cysts, head, neck, oral, and sinus surgery, mastoidectomy, myringotomy with effective hemorrhage control, nasal airway obstruction be reduction of hypertrophic nasal turbinates, nasopharyngeal/laryngeal indications including tracheal procedures, laryngeal polypectomy, and laryngeal lesion debulking, neck mass, papilloma keloids, submucosal palatal shrinkage, submucosal tissue shrinkage, tonsillectomy (including palatine tonsils), traditional uvulopalatoplasty (RAUP), tumors, and tissue in the uvula/soft palate for the treatment of snoring. It is intended for procedures using a conductive media, such as normal saline or Ringers lactate.
  • Manufacturer
    ArthroCare Corporation

Manufacturer

ArthroCare Corporation
  • 제조사 주소
    ArthroCare Corporation, 7000 W William Cannon Dr, Austin TX 78735-8509
  • 제조사 모회사 (2017)
    Smith & Nephew plc
  • Source
    USFDA