Events

HARMONIC ACE® Laparoscopic 5mm Diameter Shears + Adaptive Tissue Technology 의 안전성 경고

Food and Drug Administration Philippines에 따르면, 해당 안전성 경고 는 Philippines 에서 Johnson & Johnson Philippines, Inc. 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
  • 사례 연번
    2018-207
  • 사례 국가
    Philippines
  • 사례 출처
    FDAP
  • 사례 출처 URL
    https://ww2.fda.gov.ph//index.php/advisories-2/medical-devices-advisories-pertaining-to-all-regulated-medical-devices/514565-fda-advisory-no-2018-207
  • 비고 / 경고
    Data from the Philippines is current through 2019. All of the data comes from the Food and Drug Administration Philippines, 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 recall data from the U.S. and Philippines.
  • 데이터 추가 비고
  • 원인
    Fda advisory no. 2018-207  voluntary recall of harmonic ace® laparoscopic 5mm diameter shears + adaptive tissue technology (specific lots only for codes har23 and har36) the food and drug administration (fda) informs the public and all concerned healthcare professionals that johnson & johnson philippines, inc. has voluntarily recalled specific lots of harmonic ace® laparoscopic 5mm diameter shears + adaptive tissue technology (specific lots only for codes har23 and har36), with the following impacted lot numbers: product name product code product lots harmonic ace®+ shears with adaptive tissue technology (23cm length) har23 p9125c p93w8a p94a93 p94h9v p93t5j p93y4a p94a94 p94j28 p93t5k p93z4x p94c8r   p93v06 p93z96 p94e6u   p93w0a p9400f p94g1w   p93w4y p9409v p94h32   harmonic ace®+ shears with adaptive tissue technology (36cm length) har36 n93923 p93m6p p93u5n p94c47 n9392k p93m6t p93u90 p94c5r p9129w p93n00 p93u91 p94c8t p91394 p93n01 p93v02 p94d0m p9139n p93n3x p93v03 p94d0p p9144r p93n3y p93v0v p94d3j p9148k p93n5a p93v57 p94d3k p9149j p93n7h p93v5t p94d5g p9168k p93p09 p93w9r p94d9k p9173r p93p26 p93w9x p94e1z p9174k p93p2e p93x2g p94e20 p91795 p93p7g p93x2w p94e3z p91c51 p93p7h p93x2x p94e8w p91c83 p93r0z p93x85 p94f1m p91f2x p93r10 p93x98 p94f3a p91k69 p93r4f p93y47 p94f5t p91l0h p93r4g p93y48 p94f6c p91l1y p93r56 p93y8x p94f7l p91l6e p93r57 p93z4t p94g1h p91l6j p93r6u p93z5x p94g1j p9396a p93r6v p93z95 p94h0k p9396c p93t0x p94015 p94h31 p9399t p93t20 p9414t p94h4v p93a1l p93t26 p94a5k p94h8j p93l47 p93t9l p94a6a   p93l76 p93u0p p94c10   p93m5y p93u17 p94c11   ethicon endo-surgery, llc (“ethicon”), the manufacturer of the above-mentioned products confirmed that some devices contained in theses lots may have been assembled with an internal component that may cause continuous or inadvertent activation of the device. based on their medical assessment concluded that this situation may cause inadvertent mechanical or thermal damage to unintended tissue if the continuous or inadvertent activation occurs when used in operative cases. distributors, retailers, hospitals and all healthcare professionals / users are advised to discontinue further distribution, sale and use of the said affected medical device product.  for more information and inquiries, please e-mail us at cdrrhr_prsddthis email address is being protected from spambots. you need javascript enabled to view it. . or call us at the center for device regulation, radiation health and research (cdrrhr) hotline (02) 857-1900 local 8301. attachments: fda advisory no. 2018-207.Pdf.

Device

HARMONIC ACE® Laparoscopic 5mm Diameter Shears + Adaptive Tissue Technology

Manufacturer

Johnson & Johnson Philippines, Inc.