Events

Cooltip RFA Electrode Kits 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Nellcor Puritan Bennett Inc. (dba Covidien LP) 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
    62705
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2301-2012
  • 사례 시작날짜
    2012-08-01
  • 사례 출판 날짜
    2012-08-29
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-09-06
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=111480
  • 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
    Covidien is conducting a recall of various production lots of dghp rfa high power single use grounding pads and cool-tip rfa electrode kits due to the potential for foil degradation on the dgp-hp single use grounding pad which may result in an electrical burn to the patient at the application site.
  • 조치
    The firm, Covidien, sent an "URGENT MEDICAL DEVICE RECALL" letter dated August 6, 2012, to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately quarantine and discontinue use of the device; immediately advise all DGPHP RFA High-Power single use grounding pads and Cool-tip RF Electrode kit users of this recall; complete and return the attached Recalled Product Return Form in its entirety via fax to (800) 895-6140; return affected product to Covidien Attn: Field Returns Department, 195 McDermott Road, North Haven, CT 06473; if purchased directly from Covidien include completed form via fax or by email to : feedback.customerservice@covidien.com; if purchased from distributor complete form and contact your Distributor directly (completed form and all affected units must be returned through the Distributor); and reply to Covidien WHETHER OR NOT you have affect product at your site. If you have any questions or concerns, please do not hesitate to contact your Covidien representative or Quality Assurance, Monday through Friday, 8:30-5:00, directly at 203-492-5232.

Device

Cooltip RFA Electrode Kits
  • 모델명 / 제조번호(시리얼번호)
    ACT1020, 168583 through , 210055X; ACTC1525, 168575 through, 208115X; ACT1030, 171291 through , 209598X; ACTC2025, 168853 through, 209457X; ACT1507, 168576 through, 209455X; SWCT1530, 170383 through, 210057X; ACT1510, 170882 through , 207901X; SWCT15303, 169683 through, 207900X; ACT1520, 168571 through, 210054X; SWCT1540, 170384 through, 197330; ACT1530, 169419 through, 209547X; SWCT20303, 191407 through, 191407; ACT2020, 168854 through, 210720X; SWCT2303, 195745 through, 195745; ACT2030, 168574 through, 209453X; SWCT2530, 205456 through, 205456; ACT2530, 169684 through, 209599X; SWCT25303, 177906 through, 213729X; ACTC1025, 171300 through, 208194X; SWCT2540, 191404 through, 205455 DGPHP, 162732 through, 214867X.
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: USA (nationwide) and countries including: Australia, Brazil, Canada, Columbia, Deutchland, France, Japan, Mexico, Panama, Puerto Rico, Singapore, and Uruguay.
  • 제품 설명
    DGPHP RFA High-Power Single Use Grounding Pads and Cool-Tip RFA Electrode Kits (containing DGPHP RFA High-Power single use grounding pads) || The product is used during ablation surgical procedures.
  • Manufacturer
    Nellcor Puritan Bennett Inc. (dba Covidien LP)

Manufacturer

Nellcor Puritan Bennett Inc. (dba Covidien LP)
  • 제조사 주소
    Nellcor Puritan Bennett Inc. (dba Covidien LP), 6135 Gunbarrel Ave, Boulder CO 80301-3214
  • 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