Events

Device Recall PKG, ENDO METZENBAUM SCISSORS, CURVED 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Stryker Endoscopy 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
    69838
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0646-2015
  • 사례 시작날짜
    2014-11-17
  • 사례 출판 날짜
    2014-12-12
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2015-07-17
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=131667
  • 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
    Endoscope and/or accessories - Product Code KOG
  • 원인
    The parameters provided in the laparoscopic manual instruments instructions for use (ifu 1000-401-070 revision g or prior) do not support the unwrapped gravity cycle and the ethylene oxide cycle sterilization methods.
  • 조치
    Stryker Endoscopy sent an Urgent Device Correction letter dated November 17, 2014, to affected customers. The letter informed the customers of the potential hazards and actions required. Customers were instructed to discard any old Instructions for Use for their Laparoscopic Manual Instruments and Accessories. Download the new Instuctions for Use (IFU1000-401-070 Revision J) from the URL link below: www.stryker.com/IFU1000401070 Customers were instructed to complete and sign the enclosed "Acknowledgement of Receipt" form and email them to endorecall@stryker.com or fax to (408) 855-6314. Customers with questions were instructed to contact Stryker Endoscopy at 408-855-6238 or via email at endorecall@stryker.com. For questions regarding this recall call 408-754-2000.

Device

Device Recall PKG, ENDO METZENBAUM SCISSORS, CURVED
  • 모델명 / 제조번호(시리얼번호)
    44278 44400 140839 140841 142634 143161 144272 246221 246222 246706 246708 344732 440763 444744 444746 444747 444753 543666 543670 543676 642008 642014 642016 642021 642022 642023 647516 741834 741835 741839 741841 741842 741845 741850 742157 745055 745327 745636 746335 746336 746337 746338 746341 746348 746349 746352 746354 746979 844131 844181 844182 844184 844186 844192 844193 844196 844197 844198 844199 844201 844202 844305 844306 845990 845991 845992 845993 845995 845998 845999 846000 846001 846003 846004 846005 846006 846007 846008 846009 846010 846011 846012 846013 846014 864008 940460 940913 0943926E 0943927E 0943990E 0943991E 0943992E 0943993E 0943994E 0943995E 0943997E 0943999E 0944000E 0944001E 0944002E 0944003E 0944004E 0944006E 0944007E 0944008E 0944009E 0944010E 0944011E 0944013E 0944015E 0944016E 0944019E 0944021E 0944023E 0944025E 0944028E 0944031E 0944033E 0944035E 0944038E 0944040E 0944042E 0944044E 0944046E 0944048E 0944299E 0944669E 0944670E 0944671E 0945127E 0945213E 1022230 1042241E 1042476E 1042635E 1045242E 1045243E 1046071E 1046072E 1046074E 1046173E 1046198E 1046610E 1046849E 1046850E 1046851E 1046852E 1046853E 1046854E 1140198E 1140200E 1140201E 1141148E 1141149E 1141150E 1141609E 1142175E 1142176E 1142177E 1142178E 1142633E 1142634E 1142635E 1143088E 1143089E 1143090E 1143091E 1143452E 1143453E 1143454E 1143455E 1143456E 1143458E 1143653E 1144698E 1144699E 1144700E 1144701E 1144702E 1144703E 1144704E 1145290E 1145291E 1145292E 1145293E 1145828E 1145829E 1145830E 1145880E 1145881E 1145882E 1146384E 1146385E 1146386E 1146387E 1146573E 1146574E 1146696E 1146697E 1146698E 1147159E 1147160E 1240191E 1240192E 1240193E 1240194E 1240439E 1240440E 1240441E 1240442E 1240958E 1240959E 1240960E 1241211E 1241212E 1241213E 1241777E 1241957E 1241958E 1241959E 1241960E 1241961E 1241962E 1241963E 1241964E 1242046E 1242047E 1242048E 1242413E 1242414E 1242415E 1242416E 1242650E 1242651E 1242652E 1242653E 1242654E 1243519E 1243539E 1243592E 1243593E 1243594E 1243595E 1243808E 1243809E 1244443E 1244444 1244444E 1244445E 1244446E 1244447E 1245109E 1245110 1245110E 1245111E 1245672E 1245962E 1245964 1245964E 1245965 1245966 1245967 1245968 1246052 1246582 1246582E 1340228E 1340229 1340232 1340233 1340234 1340235 1340276 1340277 1340278 1340279 1340280 1340280E 1340281 1340282 1340283 1340283E 1340284 1340285 1340285E 1340286 1341160 1341161 1341161E 1341286 1341287 1341380 1341381 1341381E 1341382 1341382E 1341383 1341384 1341385 1341386 1341387 1341387E 1341388 1341388E 1341389 1341389E 1341390 1341390E 1341391 1341392 1341392E 1341393 1341393E 1341394 1341394E 1341395 1341395E 1341396 1341396E 1341397 1341398 1341398E 1341399 1341403 1341403E 1341404 1341404E 1341405 1341406 1341407 1341413 1341414 1341415 1342851 1343074 1343519 1343519E 1343520 1343520E 1343522 1343522E 1343523 1343523E 1343869 1343869E 1343871 1343872 1343872E 1343873 1343873E 1343874 1343875 1344088 1346551 1346553 1440341 1442300 1442553 1443204 1443301 1461962E 171899 221899 6042013 642013
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA (nationwide) and Internationally to Algeria, Argentina, Australia, Bolivia, Brazil, Canada, Chile, China, Colombia, Costa Rica, Ecuador, France, Germany, Greece, Guam, Guatemala, India, Italy, Japan, Jordan, Kuwait, Latin America, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Saudi Arabia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom, and Venezuela.
  • 제품 설명
    PKG, ENDO METZENBAUM SCISSORS, CURVED, P/N 0250080267. || Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.
  • Manufacturer
    Stryker Endoscopy

Manufacturer

Stryker Endoscopy
  • 제조사 주소
    Stryker Endoscopy, 5900 Optical Ct, San Jose CA 95138-1400
  • 제조사 모회사 (2017)
    Stryker
  • Source
    USFDA