Events

53912 Reusable External Pulse Generator Extension Cable and Model 53912A EPG Extension Cable 의 안전성 경고

Department of Health에 따르면, 해당 안전성 경고 는 Hong Kong 에서 Medtronic 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

안전성 경고는 의료기기 제품과 관련된 중요한 정보와 권고사항을 담고 있습니다. 물론 안전성 경고가 배포되었다고 해서 해당 제품이 무조건 안전하지 않은 제품이라는 것은 아닙니다. 보건의료업계 종사자와 의료기기 사용자들에게 배포되는 안전성 경고에는 회수(recall)도 포함될 수 있습니다. 제조사가 안전성 경고를 작성하기도 하지만, 보건당국에서 작성하는 경우도 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Safety alert
  • 날짜
    2017-06-15
  • 사례 출판 날짜
    2017-06-15
  • 사례 국가
    Hong Kong
  • 사례 출처
    DH
  • 사례 출처 URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20170615.html
  • 비고 / 경고
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
  • 데이터 추가 비고
    Medical Device Safety Alert
  • 원인
    Medical device safety alert: medtronic model 53912 reusable external pulse generator extension cable and model 53912a epg extension cable medical device manufacturer, medtronic, has issued a medical device safety alert concerning its model 53912 reusable external pulse generator (epg) extension cable and model 53912a epg extension cable, packaged with model 5391 epg. the affected devices are identified as follows: product names: 1) cable epg 53912 reusable; 2) epg 5391(only 53912a cables packaged with 5391 epg are affected) product numbers: 1) 53912; 2) 5391 universal product number: 1) 00643169306035, 00643169382985; 2) 00643169306028, 00643169382978 lot or serial numbers: all medtronic sells the oscor atar extension cables individually as the model 53912 reusable epg extension cable, and with 5391 epgs as the model 53912a reusable epg extension cable. according to oscor, its reusable atar extension cables could separate from the connector during use when the instructions for reuse are not being followed. the separated connector from the cable could result in the interruption of stimulation during the exchange of cable. through 20 april 2017, medtronic has identified 34 confirmed complaints with 4 reports of malfunctions during use requiring intervention to restore patient health, and no reports of death related to this issue. to minimize the potential for a connector to cable separation, or any other failure with the cables, oscor requests the users to follow the instructions defined within the current instruction for use (ifu), which indicates the number of times for reuse and requirement for re-steriliczation of the product to be conducted by the manufacturer. in addition, medtronic requests the users to carry out the following actions: limit use of these extension cables to first use + 2 re-uses after each use of the 53912 or 53912a extension cables, the cables should be sent to oscor for inspection and sterilization per the ifu. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 15 june 2017.

Device

53912 Reusable External Pulse Generator Extension Cable and Model 53912A EPG Extension Cable
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Medical Device Safety Alert: Medtronic Model 53912 Reusable External Pulse Generator Extension Cable and Model 53912A EPG Extension Cable
  • Manufacturer
    Medtronic

Manufacturer

Medtronic
  • 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
    DH