Events

Device Recall Valleylab Laparoscopic Handset 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 COVIDIEN MEDTRONIC 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
    76384
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1836-2017
  • 사례 시작날짜
    2017-01-26
  • 사례 상황
    Open, Classified
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=153021
  • 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
    Customer reports of the device handset continuing to operate after release of the activation button.
  • 조치
    A recall was initiated on January 26, 2017. Customers were notified via Federal Express and the letter instructs customers to discontinue use of the product and return all inventory to Medtronic (Covidien), 195 McDermott Road, North Haven, CT 06473, Attention: Field Returns Department. Disposition of product within Medtronic control and customer returned devices: Will be reworked.

Device

Device Recall Valleylab Laparoscopic Handset
  • 모델명 / 제조번호(시리얼번호)
    E2750: 52990142X 52990142X 52990144X 52990144X 52990147X 52990147X 52990151X 52990151X 53250057X 53250057X 53250061X 53250061X 53250063X 53250063X 53250065X 53250065X 53610053X 53610053X 53610055X 53610055X 53610059X 53610059X 53610061X 53610061X 60240055X 60240055X 60240059X 60240059X 60240061X 60240061X 60240065X 60240065X 60520098X 60520098X 60520104X 60520104X 60870064X 60870064X 61220093X 61220093X 61220095X 61220095X 61220098X 61220098X 61300164X 61300164X 61540145X 61540145X 61540150X 61540150X E2750NSB: 52990145X 53250066X 61220096X 61540146X
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide - US Nationwide Distribution in the states of: AR AZ CA CO FL GA IA IL KS KY LA MA MI MN MO MS NC NE NM NY OH OR PA SC SD TN TX VA WA WV
  • 제품 설명
    Valleylab Laparoscopic Handset; Material # E2750; Laproscopic Handset Non-Sterile Bulk; Material # E2750NSB || Product Usage: || For use in 5mm cannulas or larger cannulas with 5mm adapters during laparoscopic and thorascopic procedures. For use with a minimum peak voltage of 3625V.
  • Manufacturer
    COVIDIEN MEDTRONIC

Manufacturer

COVIDIEN MEDTRONIC
  • 제조사 주소
    COVIDIEN MEDTRONIC, 60 Middletown Ave, North Haven CT 06473-3908
  • 제조사 모회사 (2017)
    Medtronic plc
  • 제조사 의견
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA